Naproxen (DrugBank: Naproxen)
3 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 13 | Multiple sclerosis/Neuromyelitis optica | 1 |
| 46 | Malignant rheumatoid arthritis | 20 |
| 271 | Ankylosing spondylitis | 12 |
| 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 | NCT01939002 (ClinicalTrials.gov) | November 2013 | 23/8/2013 | Characterize 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 BIIB017 | Relapsing Multiple Sclerosis | Drug: BIIB017;Drug: naproxen | Biogen | NULL | Completed | 18 Years | 65 Years | All | 251 | Phase 3 | 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 | JPRN-UMIN000042632 | 2020/01/01 | 03/12/2020 | THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS | THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS - laser effectiveness in rheumatoid arthritis | Rheumatoid arthritis | low 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/Iraq | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 34 | Not applicable | Asia(except Japan) |
| 2 | NCT03699293 (ClinicalTrials.gov) | September 22, 2018 | 21/9/2018 | NSAIDs vs. Coxibs in the Presence of Aspirin | NSAIDs 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 Disease | Rheumatoid Arthritis;Cardiovascular Diseases | Drug: celecoxib 200mg capsule;Drug: naproxen sodium 550mg tablet;Drug: Aspirin 81mg tablet | Inova Health Care Services | NULL | Unknown status | 18 Years | 75 Years | All | 30 | Phase 4 | United States |
| 3 | NCT02451748 (ClinicalTrials.gov) | August 2015 | 6/5/2015 | IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA | IL-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 CIMZIA | Rheumatoid Arthritis | Other: 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: humira | University of Illinois at Chicago | UCB Pharma | Completed | 18 Years | N/A | All | 32 | Phase 4 | United States |
| 4 | EUCTR2010-021558-21-GB (EUCTR) | 28/03/2011 | 08/10/2010 | A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2a | Hungary;Slovakia;Czech Republic;Germany;United Kingdom;Ukraine | ||
| 5 | EUCTR2010-021558-21-SK (EUCTR) | 23/03/2011 | 26/10/2010 | A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2a | Hungary;Czech Republic;Germany;United Kingdom;Slovakia;Ukraine | ||
| 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 | EUCTR2010-021558-21-DE (EUCTR) | 15/02/2011 | 19/10/2010 | A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2a | Czech Republic;Hungary;Slovakia;Germany;United Kingdom | ||
| 7 | EUCTR2010-021558-21-HU (EUCTR) | 08/02/2011 | 07/10/2010 | A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2a | Hungary;Slovakia;Czech Republic;Germany;United Kingdom | ||
| 8 | EUCTR2010-021558-21-CZ (EUCTR) | 23/12/2010 | 21/10/2010 | A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2a | Hungary;Czech Republic;Slovakia;Ukraine;Germany;United Kingdom | ||
| 9 | EUCTR2008-006075-75-CZ (EUCTR) | 29/07/2009 | 28/07/2009 | A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2a | Hungary;United Kingdom;Germany;Czech Republic | ||
| 10 | EUCTR2008-006075-75-DE (EUCTR) | 22/04/2009 | 17/02/2009 | A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2a | Hungary;Czech Republic;United Kingdom;Germany | ||
| 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 | EUCTR2008-006075-75-GB (EUCTR) | 14/04/2009 | 28/04/2009 | A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2a | Hungary;Czech Republic;Germany;United Kingdom | ||
| 12 | EUCTR2008-006075-75-HU (EUCTR) | 24/03/2009 | 18/02/2009 | A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2a | Hungary;Czech Republic;United Kingdom;Germany | ||
| 13 | NCT00626275 (ClinicalTrials.gov) | October 2007 | 22/2/2008 | Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid Arthritis | A 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 Arthritis | Rheumatoid Arthritis | Drug: ADL5859;Drug: Naproxen;Drug: Placebo | Cubist Pharmaceuticals LLC | NULL | Completed | 18 Years | 75 Years | All | 46 | Phase 2 | United States |
| 14 | NCT00346216 (ClinicalTrials.gov) | October 4, 2006 | 28/6/2006 | Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen | A 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 Ibuprofen | Arthritis, Rheumatoid | Drug: celecoxib;Drug: Ibuprofen;Drug: Naproxen | Pfizer | The Cleveland Clinic | Completed | 18 Years | N/A | All | 24081 | Phase 4 | United States;Australia;Brazil;Canada;Colombia;Costa Rica;Hong Kong;Mexico;Panama;Peru;Philippines;Taiwan;Ukraine |
| 15 | 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 |
| 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 | NCT00157872 (ClinicalTrials.gov) | January 7, 2004 | 7/9/2005 | A 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 Arthritis | Rheumatoid Arthritis | Drug: MK0966; rofecoxib;Drug: Comparator: naproxen tablet 500 mg | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 150 | Phase 4 | China |
| 17 | NCT00650455 (ClinicalTrials.gov) | February 2003 | 28/3/2008 | Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients | Clinical 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 Population | Arthritis, Rheumatoid | Drug: valdecoxib;Drug: naproxen;Drug: placebo | Pfizer | NULL | Completed | 18 Years | N/A | Both | 489 | Phase 4 | United States;Canada |
| 18 | NCT00959439 (ClinicalTrials.gov) | March 2002 | 13/8/2009 | Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg) | A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg. | Rheumatoid Arthritis;Osteoarthritis | Drug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.);Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.) | Sandoz | NULL | Completed | 21 Years | 50 Years | All | 34 | Phase 1 | NULL |
| 19 | NCT00034853 (ClinicalTrials.gov) | December 2000 | 2/5/2002 | Meloxicam [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 Arthritis | Arthritis, Juvenile Rheumatoid | Drug: meloxicam oral suspension;Drug: naproxen oral suspension | Boehringer Ingelheim | NULL | Completed | 2 Years | 17 Years | Both | 180 | Phase 3 | United States;Brazil;Mexico;Ukraine;Argentina |
| 20 | NCT00279747 (ClinicalTrials.gov) | September 2000 | 19/1/2006 | A 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 Rheumatoid | Drug: meloxicam 0.25 mg/kg;Drug: meloxicam 0.125 mg/kg;Drug: naproxen 10 mg/kg | Boehringer Ingelheim | NULL | Completed | 2 Years | 16 Years | Both | 226 | Phase 3 | Austria;Belgium;France;Germany;Italy;Russian Federation;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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2010-019872-65-LT (EUCTR) | 11/04/2013 | 17/01/2013 | Etoricoxib 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. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United 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 | ||
| 2 | EUCTR2010-019872-65-CZ (EUCTR) | 10/05/2011 | 03/03/2011 | Etoricoxib 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. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United 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 | ||
| 3 | EUCTR2010-019872-65-SK (EUCTR) | 02/05/2011 | 28/02/2011 | 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 | 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: 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. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom | ||
| 4 | EUCTR2010-019872-65-AT (EUCTR) | 14/01/2011 | 03/09/2010 | Etoricoxib 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. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United 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 | ||
| 5 | EUCTR2010-019872-65-BE (EUCTR) | 11/01/2011 | 31/08/2010 | Etoricoxib 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. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United 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 | ||
| 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 | EUCTR2010-019872-65-EE (EUCTR) | 29/11/2010 | 03/11/2010 | Etoricoxib 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. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United 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 | ||
| 7 | EUCTR2010-019872-65-HU (EUCTR) | 09/11/2010 | 10/08/2010 | Etoricoxib 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. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United 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 | ||
| 8 | EUCTR2010-019872-65-FI (EUCTR) | 18/10/2010 | 30/08/2010 | Etoricoxib 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. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United 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 | ||
| 9 | NCT01208207 (ClinicalTrials.gov) | September 27, 2010 | 22/9/2010 | A 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 Spondylitis | Spondylitis, Ankylosing | Drug: 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 mg | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 1015 | Phase 3 | Argentina;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 |
| 10 | NCT00844805 (ClinicalTrials.gov) | September 2009 | 13/2/2009 | Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) | Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial | Ankylosing Spondylitis;Axial Spondyloarthritis | Drug: Infliximab;Drug: Placebo;Drug: Naproxen | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 48 Years | All | 158 | Phase 3 | Austria;Belgium;Denmark;France;Germany;Hungary;Korea, Republic of;Russian Federation;Ukraine;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 |
| 11 | 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 |
| 12 | EUCTR2010-019872-65-DE (EUCTR) | 04/08/2010 | Etoricoxib 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. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United 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 |