NAPROXEN ( DrugBank: Naproxen )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎1
46悪性関節リウマチ20
107若年性特発性関節炎4
271強直性脊椎炎13

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01939002
(ClinicalTrials.gov)
November 201323/8/2013Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-ß) Therapies to Peginterferon Beta-1a (BIIB017)An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017Relapsing Multiple SclerosisDrug: BIIB017;Drug: naproxenBiogenNULLCompleted18 Years65 YearsAll251Phase 3United States

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000042632
2020/01/0103/12/2020THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTSTHE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS - laser effectiveness in rheumatoid arthritis Rheumatoid arthritislow level laser therapy. Each patient in group 1 takes 20 sessions of LLLT , in the form of 2 courses, each course contains 10 sessions ,as 3 sessions every week ,10 days free between 2 courses.
The laser apparatuses used for therapy in this study were the following,
1.HeNe Laser wavelength 632,8 nm, continuous emission, output power 7.3 mW.
2.GaAIAs diode laser (830 nm, maximum output power 300 mW).
12 patients
placebo laser and naproxen
Naproxen is given as tablet 500mg twice per day.
12 patients
naproxen
Naproxen is given as tablet 500mg twice per day.
10 patients
Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/IraqNULLComplete: follow-up complete20years-old80years-oldMale and Female34Not applicableAsia(except Japan)
2NCT03699293
(ClinicalTrials.gov)
September 22, 201821/9/2018NSAIDs vs. Coxibs in the Presence of AspirinNSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects With Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular DiseaseRheumatoid Arthritis;Cardiovascular DiseasesDrug: celecoxib 200mg capsule;Drug: naproxen sodium 550mg tablet;Drug: Aspirin 81mg tabletInova Health Care ServicesNULLUnknown status18 Years75 YearsAll30Phase 4United States
3NCT02451748
(ClinicalTrials.gov)
August 20156/5/2015IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIAIL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIARheumatoid ArthritisOther: Lab Work;Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg);Drug: Certolizumab pegol (CDP870, tradename Cimzia);Drug: Hydroxychloroquine;Drug: Sulfasalazine;Drug: Medrol;Drug: Prednisone;Drug: Triamcinolone;Drug: Naproxen;Drug: Leflunomide;Drug: Methotrexate;Drug: humiraUniversity of Illinois at ChicagoUCB PharmaCompleted18 YearsN/AAll32Phase 4United States
4EUCTR2010-021558-21-GB
(EUCTR)
28/03/201108/10/2010A Clinical Study of AK106-001616 in Patients With Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Hungary;Slovakia;Czech Republic;Germany;United Kingdom;Ukraine
5EUCTR2010-021558-21-SK
(EUCTR)
23/03/201126/10/2010A Clinical Study of AK106-001616 in Patients With Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Hungary;Czech Republic;Germany;United Kingdom;Slovakia;Ukraine
6EUCTR2010-021558-21-DE
(EUCTR)
15/02/201119/10/2010A Clinical Study of AK106-001616 in Patients With Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Czech Republic;Hungary;Slovakia;Germany;United Kingdom
7EUCTR2010-021558-21-HU
(EUCTR)
08/02/201107/10/2010A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Hungary;Slovakia;Czech Republic;Germany;United Kingdom
8EUCTR2010-021558-21-CZ
(EUCTR)
23/12/201021/10/2010A Clinical Study of AK106-001616 in Patients With Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Hungary;Czech Republic;Slovakia;Ukraine;Germany;United Kingdom
9EUCTR2008-006075-75-CZ
(EUCTR)
29/07/200928/07/2009A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
130Phase 2Hungary;United Kingdom;Germany;Czech Republic
10EUCTR2008-006075-75-DE
(EUCTR)
22/04/200917/02/2009A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
130Phase 2Hungary;Czech Republic;United Kingdom;Germany
11EUCTR2008-006075-75-GB
(EUCTR)
14/04/200928/04/2009A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
130Phase 2Hungary;Czech Republic;Germany;United Kingdom
12EUCTR2008-006075-75-HU
(EUCTR)
24/03/200918/02/2009A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid ArthritisA Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Asahi Kasei Pharma CorporationNULLNot RecruitingFemale: yes
Male: yes
130Phase 2Hungary;Czech Republic;United Kingdom;Germany
13NCT00626275
(ClinicalTrials.gov)
October 200722/2/2008Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid ArthritisA Phase 2a Randomized, Placebo- and Active-Controlled, Single-Dose, 3-Period, Crossover Study Followed by a Randomized, Placebo-Controlled, 14-Day, Parallel-Group Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: ADL5859;Drug: Naproxen;Drug: PlaceboCubist Pharmaceuticals LLCNULLCompleted18 Years75 YearsAll46Phase 2United States
14NCT00346216
(ClinicalTrials.gov)
October 4, 200628/6/2006Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or NaproxenA Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And IbuprofenArthritis, RheumatoidDrug: celecoxib;Drug: Ibuprofen;Drug: NaproxenPfizer's Upjohn has merged with Mylan to form Viatris Inc.The Cleveland ClinicCompleted18 YearsN/AAll24081Phase 4United States;Australia;Brazil;Canada;Colombia;Costa Rica;Hong Kong;Mexico;Panama;Peru;Philippines;Taiwan;Ukraine
15NCT00367211
(ClinicalTrials.gov)
September 200618/8/2006Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.Osteoarthritis;Rheumatoid Arthritis;Ankylosing SpondylitisDrug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole)POZENNULLCompleted18 YearsN/ABoth400Phase 3United States
16NCT00157872
(ClinicalTrials.gov)
January 7, 20047/9/2005A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)A Multicenter, Randomized, Parallel-Group, 8-Week, Double-Blind, and Active Comparator-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Rofecoxib Tablet 25 mg Once Daily Versus Naproxen Table 500 mg Twice Daily in the Treatment of Chinese Patient With Rheumatoid ArthritisRheumatoid ArthritisDrug: MK0966; rofecoxib;Drug: Comparator: naproxen tablet 500 mgMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll150Phase 4China
17NCT00650455
(ClinicalTrials.gov)
February 200328/3/2008Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis PatientsClinical Protocol for a Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Bextra® (Valdecoxib) 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe RA PopulationArthritis, RheumatoidDrug: valdecoxib;Drug: naproxen;Drug: placeboPfizerNULLCompleted18 YearsN/ABoth489Phase 4United States;Canada
18NCT00959439
(ClinicalTrials.gov)
March 200213/8/2009Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg.Rheumatoid Arthritis;OsteoarthritisDrug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.);Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)SandozNULLCompleted21 Years50 YearsAll34Phase 1NULL
19NCT00034853
(ClinicalTrials.gov)
December 20002/5/2002Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With Juvenile Rheumatoid ArthritisArthritis, Juvenile RheumatoidDrug: meloxicam oral suspension;Drug: naproxen oral suspensionBoehringer IngelheimNULLCompleted2 Years17 YearsBoth180Phase 3United States;Brazil;Mexico;Ukraine;Argentina
20NCT00279747
(ClinicalTrials.gov)
September 200019/1/2006A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension 0.25mg/kg and 0.125 mg/kg Administered Once Daily in Comparison to Naproxen Oral Suspension 5mg/kg Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis.Arthritis, Juvenile RheumatoidDrug: meloxicam 0.25 mg/kg;Drug: meloxicam 0.125 mg/kg;Drug: naproxen 10 mg/kgBoehringer IngelheimNULLCompleted2 Years16 YearsBoth226Phase 3Austria;Belgium;France;Germany;Italy;Russian Federation;United Kingdom

107. 若年性特発性関節炎


臨床試験数 : 447 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01544114
(ClinicalTrials.gov)
April 201221/2/2012A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)A 6-month, Multicenter, Open-label, Safety Study of VIMOVO (250 mg/20 mg, 375 mg/20 mg, and 500 mg/20 mg Naproxen/Esomeprazole) in Adolescents Aged 12 to 16 Years, Inclusive, With Juvenile Idiopathic Arthritis (JIA)Juvenile Idiopathic Arthritis (JIA)Drug: VIMOVO 250/20;Drug: VIMOVO 375/20;Drug: VIMOVO 500/20Horizon Pharma Ireland, Ltd., Dublin IrelandNULLCompleted12 Years16 YearsAll46Phase 4United States
2NCT01358383
(ClinicalTrials.gov)
May 201116/5/2011Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult VolunteersA Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult SubjectsJuvenile Idiopathic ArthritisDrug: naproxen;Drug: esomeprazoleAstraZenecaNULLCompleted18 Years55 YearsBoth28Phase 1United States
3NCT00807846
(ClinicalTrials.gov)
September 200910/12/2008A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric SubjectsA Phase 4, 6-week, Randomized Double Blind, Multicenter, Active-controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis.Arthritis, Juvenile RheumatoidDrug: Celecoxib;Drug: NaproxenPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted2 Years17 YearsAll201Phase 4United States;Chile;Costa Rica;Peru;Philippines;Russian Federation;Serbia;South Africa;Switzerland;Ukraine
4EUCTR2014-003737-26-Outside-EU/EEA
(EUCTR)
07/04/2015A Phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial to evaluate the effects of Celecoxib (Celebrex®) or Naproxen on blood pressure in paediatric subjects with juvenile idiopathic arthritisA Phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial to evaluate the effects of Celecoxib (Celebrex®) or Naproxen on blood pressure in paediatric subjects with juvenile idiopathic arthritis Juvenile idiopathic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Celebrex
INN or Proposed INN: Celecoxib
Other descriptive name: CELECOXIB
INN or Proposed INN: Celecoxib
Other descriptive name: CELECOXIB
Product Name: Naproxen
INN or Proposed INN: NAPROXEN SODIUM
Pfizer IncNULLNAFemale: yes
Male: yes
201Phase 4South Africa;Ukraine;United States;Chile;Costa Rica;Peru;Philippines;Russian Federation;Serbia

271. 強直性脊椎炎


臨床試験数 : 574 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-019872-65-LT
(EUCTR)
11/04/201317/01/2013Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosyn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
2EUCTR2010-019872-65-CZ
(EUCTR)
10/05/201103/03/2011Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
3EUCTR2010-019872-65-SK
(EUCTR)
02/05/201128/02/2011A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing SpondylitisA Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: ARCOXIA
Product Name: etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: naproxen
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
4EUCTR2010-019872-65-AT
(EUCTR)
14/01/201103/09/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
5EUCTR2010-019872-65-BE
(EUCTR)
11/01/201131/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;South Africa;Germany
6EUCTR2010-019872-65-GB
(EUCTR)
01/12/201008/10/2010A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing SpondylitisA Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,NULLNot Recruiting Female: yes
Male: yes
1300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
7EUCTR2010-019872-65-EE
(EUCTR)
29/11/201003/11/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;South Africa;Germany
8EUCTR2010-019872-65-HU
(EUCTR)
09/11/201010/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
9EUCTR2010-019872-65-FI
(EUCTR)
18/10/201030/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
10NCT01208207
(ClinicalTrials.gov)
September 27, 201022/9/2010A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Part I - etoricoxib 60 mg;Drug: Part I - etoricoxib 90 mg;Drug: Part I- naproxen 1000 mg;Drug: Part I - Placebo to naproxen 500 mg;Drug: Part II- etoricoxib 60 mg;Drug: Part II- etoricoxib 90 mg;Drug: Part II- naproxen 1000 mg;Drug: Part I - Placebo to etoricoxib 60 mg;Drug: Part I - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to etoricoxib 60 mg;Drug: Part II - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to naproxen 500 mgOrganon and CoNULLCompleted18 YearsN/AAll1015Phase 3Argentina;Austria;Belgium;Canada;Colombia;Czech Republic;Estonia;Finland;France;Germany;Hungary;India;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovakia;South Africa;Taiwan;United Kingdom;United States
11NCT00844805
(ClinicalTrials.gov)
September 200913/2/2009Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis TrialAnkylosing Spondylitis;Axial SpondyloarthritisDrug: Infliximab;Drug: Placebo;Drug: NaproxenMerck Sharp & Dohme Corp.NULLCompleted18 Years48 YearsAll158Phase 3Austria;Belgium;Denmark;France;Germany;Hungary;Korea, Republic of;Russian Federation;Ukraine;United States
12NCT00367211
(ClinicalTrials.gov)
September 200618/8/2006Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.Osteoarthritis;Rheumatoid Arthritis;Ankylosing SpondylitisDrug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole)POZENNULLCompleted18 YearsN/ABoth400Phase 3United States
13EUCTR2010-019872-65-DE
(EUCTR)
04/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany