A 12-Month, Phase 3, Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of PN 400 - Full Text View

Purpose

This study uses an open-label design and will be conducted in approximately 60 sites aiming to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12 months exposure to PN 400.

Condition	Intervention	Phase
Gastric Ulcer	Drug: PN400	Phase III

Genetics Home Reference related topics:

ankylosing spondylitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	A 12-Month, Phase 3, Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of PN 400 in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers

Further study details as provided by Pozen:

Primary Outcome Measures:

To evaluate the long-term safety of PN 400 in subjects at risk for developing NSAID-associated upper gastrointestinal ulcers. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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

Intervention Details:

Subjects are instructed to take 2 tablets a day, one in the morning and one in the afternoon/evening. The morning tablet should be taken with water, on an empty stomach 30 to 60 minutes before breakfast, or the first meal. The afternoon/evening tablet should be taken with water, on an empty stomach 30 to 60 minutes before dinner. Tablets should be swallowed whole and not broken, crushed or chewed.

Detailed Description:

PN 400 is proposed for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 12 months in patients at risk for developing NSAID-associated gastric ulcers. This study is designed to provide long-term safety data for PN 400 in order to gain regulatory approval to make PN 400 available for clinical use in this subject population.

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: NCT00527904

Locations


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

United States, Florida
	Patient Interaction Call Center
	Pompano Beach, Florida, United States, 33069

Sponsors and Collaborators

Pozen

Investigators


Study Director:	David Taylor	Pozen

More Information

Responsible Party:	Pozen Inc. ( David Taylor )
Study ID Numbers:	PN400-304
First Received:	September 10, 2007
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00527904
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pozen:

osteoarthritis

rheumatoid arthritis

ankylosing spondylisit

NSAIDS

Subjects with a history of OA, RA, ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 12 months

Study placed in the following topic categories:

Stomach Ulcer

Stomach Diseases

Digestive System Diseases

Gastrointestinal Diseases

Osteoarthritis

Ulcer

Arthritis

Arthritis, Rheumatoid

Spondylitis, Ankylosing

Peptic Ulcer

Spondylitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2008

Sponsored by:	Pozen
Information provided by:	Pozen
ClinicalTrials.gov Identifier:	NCT00527904