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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005956-34-GB

Enrollment

320

Registered

2007-01-14

Start date

2007-03-14

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis MedDRA version: 8.1 Level: LLT Classification code 10031161 Term: Osteoarthritis

Interventions

Product Name: MK-0822 (L-001037536) Chemical name: N1-(1-cyanocyclopropyl)-4-fluoro-N2-{(1S)-2,2,2-trifluoro-1-[4’ Product Code: MK-0822 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) To evaluate the efficacy of MK-0822 5 mg once daily relative to placebo in the prevention of knee cartilage loss over 12 months of treatment based on MRI assessments of cartilage normalized volume in the medial tibial region of the knee. 2) To investigate the overall safety and tolerability of MK-0822 in OA patients over a treatment period of 12 months. ;Secondary Objective: To evaluate the efficacy of MK-0822 5 mg once daily relative to placebo in the prevention of knee cartilage loss over 12 months of treatment based on MRI assessments of cartilage normalized volume in other knee compartments.;Primary end point(s): Normalized knee cartilage volume in the medial tibial region.	—

Measure

Time frame

Main Objective: 1) To evaluate the efficacy of MK-0822 5 mg once daily relative to placebo in the prevention of knee cartilage loss over 12 months of treatment based on MRI assessments of cartilage normalized volume in the medial tibial region of the knee. 2) To investigate the overall safety and tolerability of MK-0822 in OA patients over a treatment period of 12 months. ;Secondary Objective: To evaluate the efficacy of MK-0822 5 mg once daily relative to placebo in the prevention of knee cartilage loss over 12 months of treatment based on MRI assessments of cartilage normalized volume in other knee compartments.;Primary end point(s): Normalized knee cartilage volume in the medial tibial region.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026