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12-Week No-Rofecoxib Plus Aspirin Endoscopy Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00543465
First received: October 5, 2007
Last updated: October 12, 2007
Last verified: October 2007
History of Changes
  Purpose

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).


Condition Intervention Phase
Arthritis, Rheumatoid
Osteoarthritis
 Drug: MK0782
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Study Start Date: August 2004
Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543465

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00543465     History of Changes
Other Study ID Numbers: 2007_636
Study First Received: October 5, 2007
Last Updated: October 12, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013