Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PA32540; Drug: PA32540 and celecoxib; Drug: aspirin and [NSAID]

• Registration Number: NCT00700687
• Lead Sponsor: POZEN

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-19
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-09
• Last Update Posted: 2009-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PA32540	PA32540
2	PA32540 and celecoxib	PA32540 and celecoxib
3	aspirin and [NSAID]	aspirin and celecoxib

Primary Outcome Measures

Name	Time	Method
Lanza scores	entire course of study

Secondary Outcome Measures

Name	Time	Method
safety of three treatments	entrie course of study