12-Week No-Rofecoxib Plus Aspirin Endoscopy Study

Verified by: Merck, October 2007
First Received: October 5, 2007 | Last Updated: October 12, 2007 | Phase: Phase 2 | Start Date: August 2004
Overall Status: Completed |
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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...

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).

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: MK0782

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00543465

Study ID Number: 2007_636

ClinicalTrials.gov Identifier: NCT00543465

Health Authority: United States: Food and Drug Administration

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00543465