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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:
ClinicalTrials.gov Identifier:
NCT00700687
First Posted: June 19, 2008
Last Update Posted: January 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
POZEN
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by POZEN:

Primary Outcome Measures:
  • Lanza scores [ Time Frame: entire course of study ]

Secondary Outcome Measures:
  • safety of three treatments [ Time Frame: entrie course of study ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700687


Locations
United States, California
Anaheim, California, United States
Sponsors and Collaborators
POZEN
  More Information

Responsible Party: Eric Orlemans, POZEN
ClinicalTrials.gov Identifier: NCT00700687     History of Changes
Other Study ID Numbers: PA32540-109
First Submitted: June 4, 2008
First Posted: June 19, 2008
Last Update Posted: January 12, 2009
Last Verified: January 2009

Keywords provided by POZEN:
cardiovascular prophylactic therapy

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