12-Week No-Rofecoxib Plus Aspirin Endoscopy Study (0782-003)

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 2

Conditions

Osteoarthritis

Arthritis, Rheumatoid

Treatments

Drug: MK0782

Study type

Interventional

Funder types

Industry

Identifiers

NCT00543465

2007_636

0782-003

Details and patient eligibility

About

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).

Enrollment

49 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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