29 completed, 1 terminated. 15 Phase 1, 13 Phase 3, 2 Phase 2.
By phase and status
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540
Plavix® and PA32540, EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®) - Platelet Aggregation | Phase 1 | Completed | POZEN | 30 | 2010-11-01 | 2012-03-19 |
A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin
PN400, ASA, Placebo - Platelet Inhibition | Phase 1 | Completed | AstraZeneca | 40 | 2010-03-01 | 2010-12-07 |
A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
PA32540, EC Aspirin 325 - Gastric Ulcer | Phase 3 | Completed | POZEN | 530 | 2009-10-01 | 2016-02-18 |
Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers
PA32540 - Aspirin-Associated Gastric Ulcers | Phase 3 | Completed | POZEN | 380 | 2009-10-01 | 2016-02-17 |
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
PA32540, EC-Aspirin 325 mg - Gastric Ulcer | Phase 3 | Completed | POZEN | 519 | 2009-10-01 | 2016-02-17 |
Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone
PN400, Naprosyn - Healthy | Phase 1 | Completed | AstraZeneca | 24 | 2009-09-01 | 2010-01-18 |
A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
PN 400, EC naproxen plus EC esomeprazole, EC naproxen - Arthritis | Phase 1 | Completed | POZEN | 40 | 2008-08-01 | 2008-12-23 |
Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib
celecoxib - Healthy Volunteer | Phase 1 | Completed | POZEN | 80 | 2008-07-01 | 2009-05-14 |
Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib
PA32540, PA32540 and celecoxib, aspirin and [NSAID] - Healthy | Phase 1 | Completed | POZEN | 90 | 2008-06-01 | 2009-01-12 |
Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations
PN400, Naproxen - Arthritis | Phase 1 | Completed | POZEN | 30 | 2008-06-01 | 2008-09-05 |
Study Evaluating the Effect of Food on the Bioavailability of PN400 Components
PN400 - Arthritis | Phase 1 | Completed | POZEN | 24 | 2008-05-01 | 2008-09-05 |
Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis
PN 400 (VIMOVO), celebrex, Placebo - Osteoarthritis | Phase 3 | Completed | POZEN | 614 | 2008-04-01 | 2012-02-27 |
Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis
PN 400 (VIMOVO), celebrex, Placebo - Osteoarthritis | Phase 3 | Completed | POZEN | 610 | 2008-04-01 | 2011-12-06 |
Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations
PN400, naproxen - Arthritis | Phase 1 | Completed | POZEN | 30 | 2008-03-01 | 2008-06-10 |
Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers
PA32540, aspirin component of PA32540, Ecotrin - Healthy | Phase 1 | Completed | POZEN | 36 | 2008-02-01 | 2008-03-10 |
PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400
PN400 - Healthy | Phase 1 | Completed | POZEN | 18 | 2008-01-01 | 2008-04-30 |
Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets
MT400 - Healthy | Phase 1 | Completed | GlaxoSmithKline | 42 | 2007-10-01 | 2015-04-16 |
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
PN400 (VIMOVO), Naproxen - Gastric Ulcer | Phase 3 | Completed | POZEN | 434 | 2007-09-01 | 2010-12-28 |
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
PN400 (VIMOVO), Naproxen - Gastric Ulcer | Phase 3 | Completed | POZEN | 420 | 2007-09-01 | 2010-12-28 |
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec
PN400 (VIMOVO), Diclofenac/Misoprostol - Gastric Ulcer | Phase 3 | Terminated | POZEN | 20 | 2007-09-01 | 2010-09-22 |
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Conditions studied
Stomach Ulcer (8) · Arthritis (5) · Migraine Disorders (4) · Osteoarthritis (4) · Arthritis, Rheumatoid (2) · Spondylitis, Ankylosing (1)
Interventions
Naproxen (11) · Aspirin (4) · Celecoxib (4) · Omeprazole (4) · Sumatriptan (3) · Esomeprazole (2) · lornoxicam (2) · Anti-Inflammatory Agents, Non-Steroidal (1) · Arthotec (1) · Arthrotec (1) · Clopidogrel (1) · Isradipine (1) · Ketorolac (1) · acetylsalicylic acid lysinate (1)
Countries
United States (26) · Canada (2) · Australia (1)
Top investigators
Everardus Orlemans, PhD (6) · David Taylor (4) · C. Phillip O'Carroll, MD (1) · Catherine Datto, MD (1) · Christopher Billings, DO (1) · Craig LaForce, MD (1) · David Kudrow, MD (1) · Fred Sheftell, MD (1) · Gaetano Morelli, MD (1) · Gary Berman, MD (1) · Gilbert Podolsky, MD (1) · Gregory Flippo, MD (1) · James Adelman, MD (1) · Jo Marjason (1) · John Rothrock, MD (1)
Results publications
PMID 17405970, PMID 21524238, PMID 26235613, PMID 26313454, PMID 21319944, PMID 22078153, PMID 23351820, PMID 26725920