Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis

Procter & Gamble (P&G)

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: Placebo; Drug: 50 mg PG-530742; Drug: 200 mg PG-530742; Drug: PG-530742; Drug: 100 mg PG-530742

Study type: Interventional

Funder types: Industry

Identifiers

NCT00041756

2001065

Details and patient eligibility

About

Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742 inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.

Full description

Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.

Enrollment: 395 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mild to moderate knee osteoarthritis confirmed by a radiographic technique.

Exclusion criteria

• secondary knee osteoarthritis;
• diseases other than osteoarthritis that could cause knee pain;
• any disease or intervention (surgery, intra-articular injection) that would have an impact on knee pain or mobility;
• drugs that act potentially on the bone or cartilage component of the knee joint.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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395 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo

25 mg PG-530742

Experimental group

Description:

25 mg PG-530742

Treatment:

Drug: PG-530742

50 mg PG-530742

Experimental group

Description:

50 mg PG-530742

Treatment:

Drug: 50 mg PG-530742

100 mg PG-530742

Experimental group

Description:

100 mg PG-530742

Treatment:

Drug: 100 mg PG-530742

200 mg PG-530742

Experimental group

Description:

200 mg PG-530742

Treatment:

Drug: 200 mg PG-530742