Phase III study of Tanezumab plus Diclofenac in OA of the hip or knee
Research type
Research Study
Full 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
IRAS ID
21159
Contact name
Chandrabhusan Chattopadhyay
Sponsor organisation
Pfizer Inc
Eudract number
2009-009318-41
Clinicaltrials.gov Identifier
Research summary
The predominant symptom leading to surgical intervention for osteoarthritis (OA) in hip and knee joints is pain. To spare the need for surgery and manage pain not responsive to NSAIDs, new treatments are required. Tanezumab has demonstrated positive analgesic effects in patients with OA. Patients requiring diclofenac for OA pain will be screened for eligibility, including an initial washout period and initial pain assessment period. If they meet the entry criteria, patients will be randomised into 1 of 4 groups to receive three intravenous (IV) doses of 10mg, 5mg or 2.5 mg tanezumab, or placebo at 8 week intervals. All patients will receive 75mg diclofenac twice daily. IV doses of tanezumab will be given at baseline, weeks 8 and 16. Patients will be followed for safety and efficacy until the final visit at week 32. Paracetamol may be used as rescue medication if required. Patients will attend the investigators?? clinics at regular intervals for administration of study drugs, vital signs measurements, neurologic and physical examination, clinical laboratory testing, ECG recording and the recording of concomitant medications and adverse events. Blood samples will be taken to determine the levels of tanezumab in blood plasma and also the levels of anti-drug antibody in blood serum. Patients may also consent to give an optional blood sample for genotyping. Patients will be asked to phone an Interactive Voice Response System daily while on study to report their level of OA pain and the amount of rescue medication taken. Evaluation of pain control will be made using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function subscale questionnaires and also the Patient Global Assessment of Osteoarthritis. Patients will also be asked to complete a health survey and quality of life assessment at baseline, weeks 24 and 32. Safety will be evaluated using the examinations and tests listed above.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
09/H0206/28
Date of REC Opinion
7 Aug 2009
REC opinion
Further Information Favourable Opinion