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

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ClinicalTrials.gov Identifier: NCT00543868
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

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 or disease Intervention/treatment Phase
Stomach Ulcer Duodenal Ulcer Drug: MK0782 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : June 2004
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543868


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00543868     History of Changes
Other Study ID Numbers: 0782-001
2007_637
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015

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