CompletedNCT00700687PA32540-109Updated Jan 12, 2009

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

A Phase 1 interventional study of PA32540 and PA32540 and celecoxib in Healthy, sponsored by POZEN. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-01-12.

Sponsored by POZEN · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 90
Allocation: Randomized
Ages: 50 Years and older
Sex: All

Study summary

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

Conditions studied

Healthy

Keywords

cardiovascular prophylactic therapy

In context

Lead sponsor

POZEN is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years and older
Sexes eligible: 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

Exclusion Criteria:

Standard exclusion criteria for a study of this nature

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 90 participants (estimated)

Study arms

Experimental
1
PA32540
Drug: PA32540
Experimental
2
PA32540 and celecoxib
Drug: PA32540 and celecoxib
Active comparator
3
aspirin and celecoxib
Drug: aspirin and [NSAID]

Interventions

DrugPA32540
aspirin/omeprazole
DrugPA32540 and celecoxib
aspirin/omeprazole and celecoxib
Drugaspirin and [NSAID]
aspirin and \[NSAID\]

What researchers measure

Primary outcomes

Lanza scores
Time frame: entire course of study

Secondary outcomes

safety of three treatments
Time frame: entrie course of study

Study locations

1 site

Anaheim, California, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00700687
Lead sponsor: POZEN
First posted: Jun 19, 2008
Start date: Jun 2008
Primary completion: Jul 2008
Completion: Jul 2008
Last update: Jan 12, 2009

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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