Status:
WITHDRAWN
A Study of Etoricoxib in Participants With Osteoarthritis Not Responding to Analgesic Drugs (MK-0663-142)
Lead Sponsor:
Organon and Co
Conditions:
Osteoarthritis
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
This two-part study will evaluate the effectiveness of etoricoxib in controlling pain in participants with osteoarthritis who are experiencing inadequate response to their current treatments. In Part ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of osteoarthritis of the knee or hip that requires treatment
- American Rheumatism Association (ARA) functional Class I, II or III
- Receiving a stable dose of a traditional non-steroidal anti-inflammatory drug (NSAID), a Cox-2 selective inhibitor (other than etoricoxib, e.g. celecoxib), opioid therapy or tramadol to treat their osteoarthritis-related pain for at least 2 weeks and willing to maintain treatment during baseline phase
- Moderate to severe daily pain intensity on his or her current pain regimen
- Excepting osteoarthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests
- Negative serum pregnancy test
Exclusion
- Has not experienced at least 3 consecutive days of daily pain intensity \>4 on 10-point scale
- Severe hepatic insufficiency
- Advanced renal insufficiency
- Presence of gastro-intestinal ulcer disease with active bleeding or history of the same within the past 6 months or a presence or history of inflammatory bowel disease
- History of gastric, biliary (including gastric bypass surgery), or small intestinal surgery that results in clinical malabsorption
- Receiving or will likely require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids
- Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease including a history of stroke, myocardial infarction or transient ischemic attack, and recent revascularization procedures
- Any other contraindications mentioned in the approved study drug European Union (EU) Summary of Product Characteristics (SmPC)
- Therapy with glucosamine and/or chondroitin sulfate for \<6 months prior to study start.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01429168
Start Date
October 1 2011
End Date
August 1 2012
Last Update
February 18 2022
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