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

August 1, 2008 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Abnormal baseline endoscopy.
  • Positive Helicobacter pylori serology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 18, 2006

First Posted (ESTIMATE)

August 21, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2008

Last Update Submitted That Met QC Criteria

August 1, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3175A1-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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