Tanezumab in Osteoarthritis Of The Hip

Pfizer

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis, Hip; Osteoarthritis; Arthritis

Treatments: Biological: Placebo; Biological: tanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00744471

A4091014

P3 OA HIP (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip in patients

Enrollment: 627 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoarthritis of the hip according to ACR criteria with 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 Hip injections, arthroplasty or replacement 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
• 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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627 participants in 4 patient groups

Tanezumab 10 mg

Experimental group

Description:

Tanezumab 10 mg IV every 8 weeks

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Tanezumab 5 mg

Experimental group

Description:

Tanezumab 5mg IV every 8 weeks

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Tanezumab 2.5 mg

Experimental group

Description:

Tanezumab 2.5 mg IV every 8 weeks.

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Placebo

Experimental group

Description:

Placebo

Treatment:

Biological: Placebo