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

POZEN

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: aspirin and [NSAID]; Drug: PA32540 and celecoxib; Drug: PA32540

Study type: Interventional

Funder types: Industry

Identifiers

NCT00700687

PA32540-109

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

1

Experimental group

Description:

PA32540

Treatment:

Drug: PA32540

2

Experimental group

Description:

PA32540 and celecoxib

Treatment:

Drug: PA32540 and celecoxib

3

Active Comparator group

Description:

aspirin and celecoxib

Treatment:

Drug: aspirin and [NSAID]