Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to 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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Houston, Texas, 77074, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Abnormal baseline endoscopy.
Positive Helicobacter pylori serology.

Treatment and study plan

PLA-695

Drug

Naproxen

Drug

Placebo

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Study completion: 2007
First posted: Aug 21, 2006
Registry last updated: Aug 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed