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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00543868
First received: October 5, 2007
Last updated: May 15, 2014
Last verified: May 2014

October 5, 2007
May 15, 2014
July 2004
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Complete list of historical versions of study NCT00543868 on ClinicalTrials.gov Archive Site
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MK0782 + Low-Dose Aspirin 7-Day Erosion Endoscopy Study (0782-001)
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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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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Stomach Ulcer
  • Duodenal Ulcer
Drug: MK0782
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2004
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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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00543868
0782-001, 2007_637
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP