A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers - Full Text View

Sponsored by:	Pozen
Information provided by:	Pozen
ClinicalTrials.gov Identifier:	NCT00527787

Purpose

This study uses a randomized, double-blind, controlled design and will be conducted in approximately 60 sites aiming to enroll a total number of 400 subjects (200 per arm). A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed, or the endpoint has been reached: gastric ulcer confirmed by endoscopy.

Condition	Intervention	Phase
Gastric Ulcer	Drug: PN400 Drug: naproxen	Phase III

MedlinePlus related topics: Endoscopy

Drug Information available for: Naproxen Naproxen sodium Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 400 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers

Further study details as provided by Pozen:

Primary Outcome Measures:

A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed, or the endpoint has been reached: gastric ulcer confirmed by endoscopy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	September 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PN 400 twice daily (bid)	Drug: PN400 PN 400 tablets (naproxen 500 mg and esomeprazole 20 mg) bid taken orally.
2: Active Comparator naproxen	Drug: naproxen naproxen bid

Detailed Description:

Objectives:

Primary: To demonstrate that PN 400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers.

Secondary:

To determine if PN 400 is effective in reducing the risk of duodenal ulcers in subjects at risk for developing NSAID-associated ulcers
To compare upper gastrointestinal symptoms in subjects treated with PN 400 versus naproxen as measured by scores on the Severity of Dyspepsia Assessment (SODA) instrument and the Overall Treatment Evaluation - Dyspepsia (OTE-DP)
To compare heartburn symptoms in subjects treated with PN 400 versus naproxen
To evaluate the safety and tolerability of PN 400 and naproxen

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527787

Locations

United States, California
Dennis Riff, MD
Anaheim, California, United States, 92801

Sponsors and Collaborators

Pozen

Investigators

Study Director:

David Taylor

Pozen

More Information

Responsible Party:	Pozen Inc. ( David Taylor )
Study ID Numbers:	PN400-301 & 302
Study First Received:	September 10, 2007
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00527787
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pozen:

NSAID
gastric ulcers
subjects at risk for developing NSAID-associated gastric ulcers

Study placed in the following topic categories:

Stomach Ulcer
Naproxen
Stomach Diseases
Digestive System Diseases

Gastrointestinal Diseases
Ulcer
Omeprazole
Peptic Ulcer

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Pharmacologic Actions
Pathologic Processes

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009