Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen

This study has been completed.

First Received on August 17, 2006. Last Updated on August 1, 2008 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00366262

Purpose

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	Intervention	Phase
Healthy	Drug: PLA-695 Drug: Naproxen Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

The rate of erosions and ulcers present after 7 days of treatment for PLA-65 will be compared to placebo and naproxen.

Study Start Date:	June 2006
Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier:	NCT00366262 History of Changes
Other Study ID Numbers:	3175A1-103
Study First Received:	August 17, 2006
Last Updated:	August 1, 2008
Health Authority:	United States: Food and Drug Administration

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
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012