Voltrarol SR ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ8

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
1EUCTR2004-001234-17-GR
(EUCTR)
30/01/200718/09/2006Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer HellasNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2EUCTR2004-001234-17-GB
(EUCTR)
15/06/200615/09/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer LimitedNULLNot Recruiting Female: yes
Male: yes
4402 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yesPortugal;Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden
3EUCTR2004-001234-17-SE
(EUCTR)
22/05/200627/10/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: celebra
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer ABNULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
4EUCTR2004-001234-17-PT
(EUCTR)
30/03/200626/05/2006Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Laboratórios Pfizer, LdaNULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
5EUCTR2004-001234-17-LV
(EUCTR)
27/02/200613/02/2008Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
NULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
6EUCTR2004-001234-17-IE
(EUCTR)
16/01/200602/11/2006Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer Healthcare IrelandNULLNot RecruitingFemale: yes
Male: yes
4402Phase 4Portugal;Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden
7EUCTR2004-001234-17-ES
(EUCTR)
20/12/200521/10/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse eventsDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer, S.A.NULLNot RecruitingFemale: yes
Male: yes
4402Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
8EUCTR2004-001234-17-CZ
(EUCTR)
14/12/200531/10/2005Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not ApplicableDouble-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073
Trade Name: Celebrex
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
4402Portugal;United Kingdom;Czech Republic;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden