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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
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PLA-695 Drug: Naproxen Drug: Placebo Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The rate of erosions and ulcers present after 7 days of treatment for PLA-65 will be compared to placebo and naproxen.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men or women of nonchildbearing potential, aged 18 to 60 years.

Exclusion Criteria:

  • Abnormal baseline endoscopy.
  • Positive Helicobacter pylori serology.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, Texas
Houston, Texas, United States, 77074
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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