Tanezumab in Osteoarthritis of the Knee

Pfizer

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis; Arthritis

Treatments: Biological: tanezumab; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00733902

P3 OA KNEE (Other Identifier)

A4091011

Details and patient eligibility

About

Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.

Enrollment: 697 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray grade of 2.
• Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery.
• Pain level and function levels as required by the protocol at Screening and Baseline.
• Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study.
• Must agree to the contraceptive requirements of the protocol if applicable.
• Must agree to the treatment plan, scheduled visits, and procedures of the protocol.

Exclusion criteria

• Pregnancy or intent to become pregnant during the study
• BMI greater than 39
• other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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697 participants in 4 patient groups, including a placebo group

Tanezumab 10 mg

Experimental group

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Tanezumab 5 mg

Experimental group

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Tanezumab 2.5 mg

Experimental group

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo