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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00366262

Enrollment

Unknown

Registered

2006-08-21

Start date

2006-06-30

Completion date

2007-03-31

Last updated

2008-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Health

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.

Interventions

DRUGPLA-695

DRUGNaproxen

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026