A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers
Information source: Pozen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastric Ulcer
Intervention: PN400 (Drug); naproxen (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Pozen Official(s) and/or principal investigator(s):
David Taylor, Study Director, Affiliation: Pozen
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Detailed description:
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:
- To determine if PN 400 is effective in reducing the risk of duodenal ulcers in subjects
at risk for developing NSAID-associated ulcers
- To compare upper gastrointestinal symptoms in subjects treated with PN 400 versus
naproxen as measured by scores on the Severity of Dyspepsia Assessment (SODA) instrument
and the Overall Treatment Evaluation - Dyspepsia (OTE-DP)
- To compare heartburn symptoms in subjects treated with PN 400 versus naproxen
- To evaluate the safety and tolerability of PN 400 and naproxen
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Locations and Contacts
Dennis Riff, MD, Anaheim, California 92801, United States
Additional Information
Starting date: September 2007
Ending date: August 2008
Last updated: March 20, 2008
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