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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.
Information provided by:
POZEN Identifier:
First received: June 4, 2008
Last updated: January 9, 2009
Last verified: January 2009
We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different treatments

Condition Intervention Phase
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: 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
Drug: PA32540
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]


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00700687

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

Responsible Party: Eric Orlemans, POZEN Identifier: NCT00700687     History of Changes
Other Study ID Numbers: PA32540-109
Study First Received: June 4, 2008
Last Updated: January 9, 2009

Keywords provided by POZEN:
cardiovascular prophylactic therapy

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Cyclooxygenase 2 Inhibitors processed this record on May 25, 2017