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

June 10, 2015 updated by: Merck Sharp & Dohme LLC

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

462

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 12, 2007

First Posted (Estimate)

October 15, 2007

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0782-001
  • 2007_637

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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