Celebrex (DrugBank: -)
3 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 46 | Malignant rheumatoid arthritis | 23 |
| 96 | Crohn disease | 1 |
| 271 | Ankylosing spondylitis | 3 |
| 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 | EUCTR2018-004539-54-DE (EUCTR) | 03/06/2019 | 10/04/2019 | Capability of Tofacitinib or Etanercept to accelerate clinical relevant dose reduction of non-steroidal anti-inflammatory drugs and treat-to-target guided minimization of intake of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy | Capability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy - AcceleRAte | Patients with active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz Trade Name: Enbrel Trade Name: Celebrex | Fraunhofer Fraunhofer Gesellschaft for its Fraunhofer Institute for Molecular Biology and Applied Ecology IME | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 4 | Germany | ||
| 2 | NCT02780323 (ClinicalTrials.gov) | November 2, 2015 | 19/5/2016 | Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis | A Multi-center, Double-blind, Active-controlled, Randomized, Parallel-group Clinical Trial to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CELBESTA®;Drug: CELEBREX®;Drug: CELEBREX® placebo;Drug: CELBESTA® placebo | Dong-A ST Co., Ltd. | NULL | Completed | 19 Years | N/A | All | 119 | Phase 4 | Korea, Republic of |
| 3 | EUCTR2007-000012-90-NL (EUCTR) | 01/06/2011 | 18/10/2010 | The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial | The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial | The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure. MedDRA version: 9.1;Level: LLT;Classification code 10041591;Term: Spinal osteoarthritis MedDRA version: 9.1;Classification code 10003268;Term: Arthritis rheumatoid | Trade Name: Celebrex Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses | University of Dundee | NULL | Not Recruiting | Female: yes Male: yes | Denmark;Netherlands;United Kingdom | ||||
| 4 | NCT01781702 (ClinicalTrials.gov) | October 2010 | 30/1/2013 | Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients | A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients | Pelubiprofen;Celebrex;Rheumatoid Arthritis | Drug: Pelubiprofen 30 mg;Drug: Celebrex 200 mg | Daewon Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | 80 Years | Both | 120 | Phase 3 | NULL |
| 5 | EUCTR2007-000012-90-GB (EUCTR) | 23/01/2008 | 28/03/2007 | The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial | The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial | The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure. MedDRA version: 13.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 13.1;Level: PT;Classification code 10041591;Term: Spinal osteoarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Celebrex Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses | University of Dundee | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark;Netherlands;United Kingdom | |||
| 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 |
| 6 | 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 | ||||
| 7 | 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 | ||||
| 8 | 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 | |||
| 9 | EUCTR2005-000158-61-LT (EUCTR) | 03/05/2006 | 06/01/2006 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celebrex INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | |||
| 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 | |||
| 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 |
| 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 | EUCTR2005-000158-61-CZ (EUCTR) | 18/01/2006 | 05/12/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Czech Republic;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania;Hungary;Germany;United Kingdom | |||
| 15 | 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 | |||
| 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 |
| 16 | EUCTR2005-000158-61-EE (EUCTR) | 16/01/2006 | 11/11/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | |||
| 17 | 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 | |||
| 18 | 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 | |||
| 19 | 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 | |||
| 20 | EUCTR2005-000158-61-IE (EUCTR) | 21/10/2005 | 13/09/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: Celebrex Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Spain;Ireland;Italy;Latvia;Lithuania | |||
| 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 |
| 21 | EUCTR2005-000158-61-AT (EUCTR) | 10/08/2005 | 07/06/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Czech Republic;Estonia;Hungary;Spain;Ireland;Lithuania;Denmark;Austria;Germany;Latvia;Italy;United Kingdom | ||
| 22 | EUCTR2005-000158-61-GB (EUCTR) | 18/07/2005 | 27/05/2005 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: Celebrex 200 mg capsule, hard Product Name: Celecoxib INN or Proposed INN: Celecoxib | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 2210 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania | |||
| 23 | EUCTR2005-000158-61-IT (EUCTR) | 09/06/2005 | 05/01/2006 | A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis - | RHEUMATOID ARTHRITIS MedDRA version: 6.1;Level: PT;Classification code 10039073 | Product Name: GW406381 Product Code: GW406381 Product Name: GW406381 Product Code: GW406381 Product Name: GW406381 Product Code: GW406381 Product Name: GW406381 Product Code: GW406381 Trade Name: CELEBREX 200MG 20CPS INN or Proposed INN: Celecoxib | GLAXO SMITHKLINE | NULL | Not Recruiting | Female: yes Male: yes | 2208 | Phase 3 | Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania |
| 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 | NCT00177866 (ClinicalTrials.gov) | December 2003 | 13/9/2005 | Safety of Celecoxib in Patients With Crohn's Disease | The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease | Crohn's Disease | Drug: Celebrex;Drug: placebo | University of Pittsburgh | Shadyside Hospital Foundation;Pfizer | Terminated | 18 Years | 70 Years | All | 28 | Phase 4 | United States |
| 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 | EUCTR2016-000615-33-DE (EUCTR) | 29/07/2016 | 06/07/2016 | Comparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis: a randomized controlled multicentre trial (CONSUL) | Comparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis: a randomized controlled multicentre trial (CONSUL) - CONSUL | ankylosing spondylitis (AS) MedDRA version: 21.1;Level: LLT;Classification code 10041672;Term: Spondylitis ankylosing;System Organ Class: 100000004859 MedDRA version: 21.1;Classification code 10048398;Term: Spondylitis ankylosing aggravated;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Simponi Trade Name: Celebrex | Charite Universitaetsmedizin | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 4 | Germany | ||
| 2 | NCT01934933 (ClinicalTrials.gov) | September 24, 2014 | 17/8/2013 | Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis | A Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: celebrex;Drug: Enbrel;Drug: Enbrel plus Celebrex | Sun Yat-sen University | NULL | Completed | 18 Years | 65 Years | All | 150 | Phase 4 | China |
| 3 | NCT01709656 (ClinicalTrials.gov) | March 2012 | 10/10/2012 | A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis | A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis | Ankylosing Spondylitis | Biological: MSC;Drug: celecoxib, Celebrex® | Sun Yat-sen University | NULL | Completed | 16 Years | 65 Years | Both | 120 | N/A | China |