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Sponsored by: |
Pozen |
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Information provided by: | Pozen |
ClinicalTrials.gov Identifier: | NCT00527787 |
This study uses a randomized, double-blind, controlled design and will be conducted in approximately 60 sites aiming to enroll a total number of 400 subjects (200 per arm). A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed, or the endpoint has been reached: gastric ulcer confirmed by endoscopy.
Condition | Intervention | Phase |
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Gastric Ulcer |
Drug: PN400 Drug: naproxen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 400 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers |
Estimated Enrollment: | 400 |
Study Start Date: | September 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
PN 400 twice daily (bid)
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Drug: PN400
PN 400 tablets (naproxen 500 mg and esomeprazole 20 mg) bid taken orally.
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2: Active Comparator
naproxen
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Drug: naproxen
naproxen bid
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Objectives:
Primary: To demonstrate that PN 400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers.
Secondary:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Responsible Party: | Pozen Inc. ( David Taylor ) |
Study ID Numbers: | PN400-301 & 302 |
Study First Received: | September 10, 2007 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00527787 |
Health Authority: | United States: Food and Drug Administration |
NSAID gastric ulcers subjects at risk for developing NSAID-associated gastric ulcers |
Stomach Ulcer Naproxen Stomach Diseases Digestive System Diseases |
Gastrointestinal Diseases Ulcer Omeprazole Peptic Ulcer |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Gout Suppressants Pharmacologic Actions Pathologic Processes |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |