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

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00700687
First received: June 4, 2008
Last updated: January 9, 2009
Last verified: January 2009
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib

Resource links provided by NLM:

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
Experimental: 1
PA32540
 Drug: PA32540
aspirin/omeprazole
Experimental: 2
PA32540 and celecoxib
 Drug: PA32540 and celecoxib
aspirin/omeprazole and celecoxib
Active Comparator: 3
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: Eric Orlemans, POZEN
ClinicalTrials.gov Identifier: NCT00700687     History of Changes
Other Study ID Numbers: PA32540-109
Study First Received: June 4, 2008
Last Updated: January 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by POZEN:
cardiovascular prophylactic therapy

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Celecoxib
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
 Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013