Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: PLA-695 (Drug); Naproxen (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
The purpose of this study is to provide an initial assessment of the gastrointestinal safety
of a 7-day regimen of PLA-695 compared to placebo or naproxen.
Clinical Details
Official title: A Randomized, Double-Blind, Parallel Group Study To Compare The 7-Day Gastrointestinal Safety of 2 Doses of PLA-695 To That Of Placebo And Naproxen
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: The rate of erosions and ulcers present after 7 days of treatment for PLA-65 will be compared to placebo and naproxen.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy men or women of nonchildbearing potential, aged 18 to 60 years.
Exclusion Criteria:
- Abnormal baseline endoscopy.
- Positive Helicobacter pylori serology.
Locations and Contacts
Houston, Texas 77074, United States
Additional Information
Starting date: June 2006
Ending date: March 2007
Last updated: December 11, 2007
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