CompletedPhase 3

Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

United States400 participantsStarted 2006-09

Plain-language summary

The purpose of this study is to evaluate the incidence of gastric ulcers following administration of either PN 200 or Naproxen in subjects who are at risk for developing NSAID-associated ulcers.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
✓. Childbearing potential, have a negative pregnancy test (urine) at screening, and at least one of the following applies or is agreed to by the subject:

What they're measuring

The primary efficacy variable is the incidence of gastric ulcers, defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with depth, at anytime throughout 6 months of study treatment.

Trial details

NCT IDNCT00367211

SponsorPOZEN

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-09

View on ClinicalTrials.gov More Osteoarthritis trials