Text Size

MK0782 + Low-Dose Aspirin 7-Day Erosion Endoscopy Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00543868
First received: October 5, 2007
Last updated: October 12, 2007
Last verified: October 2007
History of Changes
  Purpose

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).


Condition Intervention Phase
Stomach Ulcer
Duodenal Ulcer
 Drug: MK0782
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Merck:

Study Start Date: July 2004
Study Completion Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543868

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00543868     History of Changes
Other Study ID Numbers: 2007_637
Study First Received: October 5, 2007
Last Updated: October 12, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Duodenal Ulcer
Stomach Ulcer
Ulcer
Peptic Ulcer
Duodenal Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013