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.
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|ClinicalTrials.gov Identifier: NCT00367211|
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : April 22, 2008
|Condition or disease||Intervention/treatment||Phase|
|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)||Phase 3|
POZEN has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|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 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.|
|Study Start Date :||September 2006|
|Primary Completion Date :||September 2007|
|Study Completion Date :||September 2007|
U.S. FDA Resources
- The primary efficacy variable is the incidence of gastric ulcers, defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with depth, at anytime throughout 6 months of study treatment.
- The secondary efficacy variable is the incidence of duodenal ulcers at any time throughout 6 months of treatment, tolerability and safety.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367211
|United States, Florida|
|Pompano Beach, Florida, United States, 33069|