Back to resultsMK0782 + Low-Dose Aspirin 7-Day Erosion Endoscopy Study (0782-001)
Primary Purpose
Stomach Ulcer, Duodenal Ulcer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0782
Sponsored by
About this trial
This is an interventional prevention trial for Stomach Ulcer
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00543868
Brief Title
MK0782 + Low-Dose Aspirin 7-Day Erosion Endoscopy Study (0782-001)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Ulcer, Duodenal Ulcer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
462 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0782
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
MK0782 + Low-Dose Aspirin 7-Day Erosion Endoscopy Study (0782-001)
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