46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04246762 (ClinicalTrials.gov) | April 6, 2021 | 27/1/2020 | Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4 | A Phase 1, Open-label, Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4 | Rheumatoid Arthritis | Drug: Olokizumab;Drug: Omeprazole;Drug: Caffeine;Drug: Warfarin+ Vitamin K;Drug: Midazolam | R-Pharm International, LLC | IQVIA RDS Ireland Ltd;Thermo Fisher Scientific | Recruiting | 18 Years | 70 Years | All | 15 | Phase 1 | Bulgaria;Moldova, Republic of |
| 2 | NCT03131973 (ClinicalTrials.gov) | May 13, 2017 | 25/4/2017 | Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin | Effects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy Participants | Rheumatoid Arthritis | Drug: BMS-986195;Drug: Methotrexate;Drug: Leucovorin;Drug: Caffeine;Drug: Montelukast;Drug: Flurbiprofen;Drug: Omeprazole;Drug: Midazolam;Drug: Digoxin;Drug: Pravastatin | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | All | 26 | Phase 1 | United States |
| 3 | NCT02762123 (ClinicalTrials.gov) | May 2016 | 3/5/2016 | A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates | Effects of Concomitant Administration of BMS-986142 on the Single-dose Pharmacokinetics of Probe Substrates for CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-gp in Healthy Subjects | Rheumatoid Arthritis | Drug: BMS-986142 200mg;Drug: BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin);Drug: BMS-986142 350mg | Bristol-Myers Squibb | NULL | Completed | 18 Years | 50 Years | Both | 28 | Phase 1 | United States |
| 4 | NCT01636557 (ClinicalTrials.gov) | October 11, 2012 | 6/7/2012 | A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis | A Phase I, Open-label, Drug Interaction Study to Evaluate the Effect of a Single-dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Subjects With Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Sirukumab;Drug: Midazolam;Drug: Warfarin;Drug: Vitamin K;Drug: Omeprazole;Drug: Caffeine | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 65 Years | All | 12 | Phase 1 | Germany;Korea, Republic of;Moldova, Republic of;South Africa |
| 5 | EUCTR2004-001234-17-GR (EUCTR) | 30/01/2007 | 18/09/2006 | Double-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 | Double-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 Hellas | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden | ||||
| 6 | EUCTR2004-001234-17-EE (EUCTR) | 22/01/2007 | 29/12/2005 | Double-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 - N/A | Double-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 - N/A | 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: Voltarol SR (generics also available in the EU) Product Name: Voltarol 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 Inc. New York | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden | ||||
| 7 | NCT00367211 (ClinicalTrials.gov) | September 2006 | 18/8/2006 | 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. | 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 Spondylitis | Drug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole) | POZEN | NULL | Completed | 18 Years | N/A | Both | 400 | Phase 3 | United States |
| 8 | EUCTR2004-001234-17-GB (EUCTR) | 15/06/2006 | 15/09/2005 | Double-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 | Double-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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 4402 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yes | Portugal;Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden | ||
| 9 | EUCTR2004-001234-17-SE (EUCTR) | 22/05/2006 | 27/10/2005 | Double-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 | Double-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 AB | NULL | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden | |||
| 10 | EUCTR2004-001234-17-PT (EUCTR) | 30/03/2006 | 26/05/2006 | Double-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 | Double-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, Lda | NULL | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden | |||
| 11 | EUCTR2004-001234-17-DE (EUCTR) | 20/03/2006 | 14/12/2005 | Double-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 - CONDOR | Double-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 - CONDOR | 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 200 mg Hartkapseln Product Name: Celebrex INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)- 1H-pyrazol-1-yl] benzenesulfonamide Trade Name: Voltarol SR Product Name: Voltarol SR INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]- phenyl]-acetate Trade Name: Losec Capsules 20 mg 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 Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;Estonia;Czech Republic;Greece;Spain;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden | |||
| 12 | EUCTR2004-001234-17-LV (EUCTR) | 27/02/2006 | 13/02/2008 | Double-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 | Double-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 | NULL | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden | ||||
| 13 | EUCTR2004-001234-17-BE (EUCTR) | 02/02/2006 | 24/10/2005 | Double-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 - N/A | Double-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 - N/A | 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: Voltarol SR (generics also available in the EU) Product Name: Voltarol 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 SA/NV | NULL | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;Estonia;Czech Republic;Greece;Spain;Belgium;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden | |||
| 14 | EUCTR2004-001234-17-IE (EUCTR) | 16/01/2006 | 02/11/2006 | Double-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 | Double-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 Ireland | NULL | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;Czech Republic;United Kingdom;Estonia;Spain;Ireland;Greece;Latvia;Lithuania;Sweden | |||
| 15 | EUCTR2004-001234-17-LT (EUCTR) | 29/12/2005 | 23/11/2005 | Double-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 - N/A | Double-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 - N/A | Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | 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: Voltarol SR (generics also available in the EU) Product Name: Voltarol 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 Inc. | NULL | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Sweden;Lithuania | |||
| 16 | EUCTR2004-001234-17-ES (EUCTR) | 20/12/2005 | 21/10/2005 | Double-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 | Double-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. | NULL | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden | |||
| 17 | EUCTR2004-001234-17-CZ (EUCTR) | 14/12/2005 | 31/10/2005 | Double-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 | Double-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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 4402 | Portugal;United Kingdom;Czech Republic;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden | |||
| 18 | NCT00141102 (ClinicalTrials.gov) | October 2005 | 29/8/2005 | Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis | Double-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 | Osteoarthritis;Arthritis, Rheumatoid | Drug: Celecoxib;Drug: Diclofenac + Omeprazole | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | N/A | All | 4484 | Phase 4 | Belgium;Brazil;Canada;China;Colombia;Costa Rica;Croatia;Czechia;Ecuador;Estonia;France;Germany;Greece;Guatemala;Hong Kong;India;Korea, Republic of;Latvia;Lithuania;Netherlands;Panama;Peru;Portugal;Russian Federation;Serbia;Singapore;South Africa;Spain;Sweden;Taiwan;Ukraine;United Kingdom;Czech Republic;Former Serbia and Montenegro;Ireland |