A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee (ITIC)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: SD-6010; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00565812

ITIC (Other Identifier)

2007-001457-26 (EudraCT Number)

A6171016

Details and patient eligibility

About

The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.

Enrollment: 1,457 patients

Sex: All

Ages: 40 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects aged >= 40 years with a BMI >= 25 and <= 40 kg/m2
• In the past, has been diagnosed with knee OA
• Radiographic evidence of OA in the study knee

Exclusion criteria

• A diagnosis of any other rheumatic disease
• Current conditions in the study knee that would confound efficacy
• Selected, traditional clinical safety and laboratory parameters

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,457 participants in 3 patient groups, including a placebo group

200 mg

Active Comparator group

Description:

High dose active comparator

Treatment:

Drug: SD-6010

Drug: SD-6010

50 mg

Active Comparator group

Description:

Low dose active comparator

Treatment:

Drug: SD-6010

Drug: SD-6010

Placebo

Placebo Comparator group

Description:

Placebo comparator to be used for control purposes

Treatment:

Drug: Placebo