MK0782 + Low-Dose Aspirin 7-Day Erosion Endoscopy Study (0782-001)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2004-08-31

Brief Summary

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This study will determine how if MK0782 is safe and tolerable and to determine how often and the severity of stomach and small intestine ulcers develop following administration of MK0782 plus enteric coated aspirin, rofecoxib 25mg plus enteric coated aspirin, naproxen 500 mg puls enteric coated asprin vs placebo.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

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Detailed Description

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Conditions

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Stomach Ulcer Duodenal Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0782

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or non pregnant female
* 18 years of age or older (age at consent)
* Able to abstain from alcohol, tobacco, spicy foods, limit coffee
* Able to avoid strenuous activity
* Able to read and fill out a study diary

Exclusion Criteria

* You have participated in an investigational drug study within 4 weeks of entering this study
* Your weight is not within a specific range for the study
* You have a history of GI problems like a gastric ulcer
* You have had gastric or intestinal surgery
* You have had abdominal or chest surgery
* You are currently abusing drugs or alcohol or have a history of abuse
* You have a history of psychiatric disorders
* You are a smoker or have smoked during the last year

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes