NCT00366262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2006

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

August 5, 2008

Status Verified

August 1, 2008

First QC Date

August 17, 2006

Last Update Submit

August 1, 2008

Conditions

Healthy

Keywords

Health

Outcome Measures

Primary Outcomes (1)

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

Interventions

PLA-695DRUG
NaproxenDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Abnormal baseline endoscopy.
  • Positive Helicobacter pylori serology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Houston, Texas, 77074, United States

Location

MeSH Terms

Interventions

PLA-695Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

June 1, 2006

Study Completion

March 1, 2007

Last Updated

August 5, 2008

Record last verified: 2008-08

Locations

US(1)