Back to results12-Week No-Rofecoxib Plus Aspirin Endoscopy Study (0782-003)
Primary Purpose
Arthritis, Rheumatoid, Osteoarthritis
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0782
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid
Eligibility Criteria
Inclusion Criteria:
- Has osteoarthritis or rheumatoid arthritis for at least 6 months prior to start of study
- Osteoarthritis (OA): must have diagnosis of OA in knee, hip, hand or spine
Patient is not on chronic aspirin therapy (taking aspirin at any dose, on a daily basis, for a minimum of 4 weeks prior to Visit 2 for any medical condition
- Must be willing to limit alcohol use to no more than 2 drinks per day
- Avoid strenuous physical activity
Exclusion Criteria:
- Mentally or legally incapacitated
- Has systemic lupus erythematosus, Paget's disease
- Has a history of esophageal, gastric biliary, or small intestine surgery (hiatal surgeries and any GI surgery that causes clinical malabsorption or delayed gastric emptying
- Has uncontrolled hypertension
- Has uncontrolled diabetes
- Has had heart attack, unstable angina, coronary angioplasty, stent placement, coronary artery bypass grafting in the last 6 months
- Has congestive heart failure
- Has had active liver disease within the last 2 years
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00543465
Brief Title
12-Week No-Rofecoxib Plus Aspirin Endoscopy Study (0782-003)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Study Start Date
August 2004 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 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 look at the incidence of gastric and/or duodenal ulcers in patients with osteoarthritis or rheumatoid arthritis in four different treatment groups (a) MK0782 21 mg plus enteric-coated aspirin, (b) MK0782 42 mg plus enteric-coated aspirin, (c) celecoxib 200 mg plus enteric-coated aspirin, and enteric-coated aspiring alone.
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
Arthritis, Rheumatoid, Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0782
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has osteoarthritis or rheumatoid arthritis for at least 6 months prior to start of study
Osteoarthritis (OA): must have diagnosis of OA in knee, hip, hand or spine
Patient is not on chronic aspirin therapy (taking aspirin at any dose, on a daily basis, for a minimum of 4 weeks prior to Visit 2 for any medical condition
Must be willing to limit alcohol use to no more than 2 drinks per day
Avoid strenuous physical activity
Exclusion Criteria:
Mentally or legally incapacitated
Has systemic lupus erythematosus, Paget's disease
Has a history of esophageal, gastric biliary, or small intestine surgery (hiatal surgeries and any GI surgery that causes clinical malabsorption or delayed gastric emptying
Has uncontrolled hypertension
Has uncontrolled diabetes
Has had heart attack, unstable angina, coronary angioplasty, stent placement, coronary artery bypass grafting in the last 6 months
Has congestive heart failure
Has had active liver disease within the last 2 years
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
12-Week No-Rofecoxib Plus Aspirin Endoscopy Study (0782-003)
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