Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen
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ClinicalTrials.gov Identifier: NCT00366262 |
Recruitment Status
:
Completed
First Posted
: August 21, 2006
Last Update Posted
: August 5, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: PLA-695 Drug: Naproxen Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 Start Date : | June 2006 |
Actual Study Completion Date : | March 2007 |
- The rate of erosions and ulcers present after 7 days of treatment for PLA-65 will be compared to placebo and naproxen.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy men or women of nonchildbearing potential, aged 18 to 60 years.
Exclusion Criteria:
- Abnormal baseline endoscopy.
- Positive Helicobacter pylori serology.

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): NCT00366262
United States, Texas | |
Houston, Texas, United States, 77074 |
Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT00366262 History of Changes |
Other Study ID Numbers: |
3175A1-103 |
First Posted: | August 21, 2006 Key Record Dates |
Last Update Posted: | August 5, 2008 |
Last Verified: | August 2008 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Health |
Additional relevant MeSH terms:
Naproxen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Inflammatory Agents Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |