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

Condition(s) targeted: Osteoarthritis

Intervention: tanezumab (Biological); diclofenac (Drug); tanezumab (Biological); diclofenac (Drug); tanezumab (Biological); diclofenac (Drug); diclofenac (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: A Phase 3, Randomized, Double-Blind, Controlled, Multi-Center Study Of The Analgesic Efficacy And Safety Of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Western Ontario and McMaster Universities (WOMAC) Pain Subscale

WOMAC Physical Function Subscale

Patient Global Assessment of Osteoarthritis

Secondary outcome:

Adverse events

SF-36v2 Health Survey (8 domains plus Physical Component Summary and Mental Component Summary

Patient Global Assessment of Osteoarthritis

WOMAC pain, physical function and stiffness subscales

Average of daily pain scores in index knee or hip

EQ-5D

Time to discontinuation

Safety (laboratories for chemistry, hematology,urinalysis; ECGs; physical exams; vital signs; neurologic exams; serum anti-drug antibody assessments; pregnancy tests (where applicable)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Graz A-8036, Austria; Not yet recruiting

Pfizer Investigational Site, Wien A-1100, Austria; Recruiting

Pfizer Investigational Site, Kyiv 01023, Ukraine; Not yet recruiting

Pfizer Investigational Site, Lviv 79013, Ukraine; Not yet recruiting

To obtain contact information for a study center near you, click here.

Starting date: August 2009
Ending date: September 2010
Last updated: September 18, 2009