A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK-0822 in Patients with Osteoarthritis - Safety and Efficacy of MK-0822 in Patients with Osteoarthritis

Phase 1

• Conditions: Osteoarthritis; MedDRA version: 8.1 Level: LLT Classification code 10031161 Term: Osteoarthritis

• Registration Number: EUCTR2006-005956-34-GB
• Lead Sponsor: Merck Sharp & Dohme Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-14
• Study Completion: 2007-04-23
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 320

Inclusion Criteria

Clinical and radiographic diagnosis of OA in medial tibio-femoral joint of the knee for at least 6 months per ACR classification criteria; in general good health with a certain level of knee pain or taking pain medications on most days; enrichment criteria for OA progression (BMI = 25 kg/m2, radiographic and MRI criteria associated with an increased risk of OA progression in the index knee).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Inflammatory arthritis, other generative arthritis, or fibromyalgia; ineligibility for MRI scan; previous septic arthritis, tibial osteotomy or knee replacement, acute ligamentous or meniscal injury within past 2 years; knee arthroscopy within the past 12 months; hip/ankle arthroscopy or podiatric surgery within past 6 months; intra-articular injections of hyaluronan in past 6 months, or injections of glucocorticoids within past 3 months; change in dose of glucosamine or chondroitin sulfate within past 3 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified