Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib - Full Text View

Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib (PA32540-109)

This study has been completed.

First Received: June 4, 2008 Last Updated: January 9, 2009 History of Changes

Sponsor:	POZEN
Information provided by:	POZEN
ClinicalTrials.gov Identifier:	NCT00700687

Purpose

We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different treatments

Condition	Intervention	Phase
Healthy	Drug: PA32540 Drug: PA32540 and celecoxib Drug: aspirin and [NSAID]	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Celecoxib

U.S. FDA Resources

Further study details as provided by POZEN:

Primary Outcome Measures:

Lanza scores [ Time Frame: entire course of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

safety of three treatments [ Time Frame: entrie course of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	June 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PA32540	Drug: PA32540 aspirin/omeprazole
2: Experimental PA32540 and celecoxib	Drug: PA32540 and celecoxib aspirin/omeprazole and celecoxib
3: Active Comparator aspirin and celecoxib	Drug: aspirin and [NSAID] aspirin and [NSAID]

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or non-pregnant female subjects greater than or equal to 50 years as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

Standard exclusion criteria for a study of this nature

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700687

Locations

United States, California

Anaheim, California, United States

Sponsors and Collaborators

POZEN

More Information

No publications provided

Responsible Party:	POZEN ( Eric Orlemans )
Study ID Numbers:	PA32540-109
Study First Received:	June 4, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00700687 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by POZEN:

cardiovascular prophylactic therapy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

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

ClinicalTrials.gov processed this record on February 08, 2010