Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Osteoarthritis

Treatments: Other: IV placebo; Biological: tanezumab; Drug: diclofenac

Study type: Interventional

Funder types: Industry

Identifiers

NCT00864097

2009-009318-41 (EudraCT Number)

P3 6 MO OA HIP/KNEE DICLOFENAC (Other Identifier)

A4091017

Details and patient eligibility

About

The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.

Full description

This study was terminated on 16 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Enrollment: 607 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence X-ray grade equal to, or greater than, 2.
• Patients must be experiencing some benefit from their current stable dose regimen of oral diclofenac 150 mg/day and be tolerating their diclofenac regimen.
• Pain and function levels as required by the protocol at Screening and Baseline.
• Willing to discontinue all non-study pain medications throughout the study except as permitted per protocol.
• Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion criteria

• Pregnant women.
• BMI greater than 39.
• History of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (RA), joint infections, neuropathic disorders, avascular necrosis, Paget's disease or tumors.
• Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA.
• Signs and symptoms of clinically significant cardiac disease within 6 months prior to screening.
• Diagnosis or TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
• History, diagnosis , signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
• At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 150 micro-mol/L in men or 133 micro-mol/L in women.
• Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to Screening.
• Known hypersensitivity to NSAIDs (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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607 participants in 4 patient groups, including a placebo group

Tanezumab 10 mg + diclofenac

Experimental group

Description:

IV tanezumab 10 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)

Treatment:

Biological: tanezumab

Drug: diclofenac

Drug: diclofenac

Biological: tanezumab

Drug: diclofenac

Drug: diclofenac

Biological: tanezumab

Tanezumab 5 mg + diclofenac

Experimental group

Description:

IV tanezumab 5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)

Treatment:

Biological: tanezumab

Drug: diclofenac

Drug: diclofenac

Biological: tanezumab

Drug: diclofenac

Drug: diclofenac

Biological: tanezumab

Tanezumab 2.5 mg + diclofenac

Experimental group

Description:

IV tanezumab 2.5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)

Treatment:

Biological: tanezumab

Drug: diclofenac

Drug: diclofenac

Biological: tanezumab

Drug: diclofenac

Drug: diclofenac

Biological: tanezumab

IV placebo + diclofenac

Placebo Comparator group

Description:

IV placebo to match tanezumab every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)

Treatment:

Other: IV placebo

Drug: diclofenac

Drug: diclofenac

Drug: diclofenac

Drug: diclofenac