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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00864097

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis	Biological: tanezumab Drug: diclofenac Other: IV placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Western Ontario and McMaster Universities (WOMAC) Pain Subscale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
WOMAC Physical Function Subscale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Patient Global Assessment of Osteoarthritis [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
SF-36v2 Health Survey (8 domains plus Physical Component Summary and Mental Component Summary [ Time Frame: Weeks 12, 24 ] [ Designated as safety issue: No ]
Patient Global Assessment of Osteoarthritis [ Time Frame: Weeks 2, 4, 8, 12, 24 ] [ Designated as safety issue: No ]
WOMAC pain, physical function and stiffness subscales [ Time Frame: Weeks 2, 4, 8, 12, 24 ] [ Designated as safety issue: No ]
Average of daily pain scores in index knee or hip [ Time Frame: Weeks 1-24 ] [ Designated as safety issue: No ]
EQ-5D [ Time Frame: Weeks 24 ] [ Designated as safety issue: No ]
Time to discontinuation [ Time Frame: All weeks ] [ Designated as safety issue: No ]
Safety (laboratories for chemistry, hematology,urinalysis; ECGs; physical exams; vital signs; neurologic exams; serum anti-drug antibody assessments; pregnancy tests (where applicable) [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]

Enrollment:	607
Study Start Date:	August 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tanezumab 10 mg + diclofenac IV tanezumab 10 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)	Biological: tanezumab IV tanezumab 10 mg every 8 weeks (through Week 16) Drug: diclofenac Oral diclofenac SR 75 mg BID for 32 weeks
Experimental: Tanezumab 5 mg + diclofenac IV tanezumab 5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)	Biological: tanezumab IV tanezumab 5 mg every 8 weeks (through Week 16) Drug: diclofenac Oral diclofenac SR 75 mg BID for 32 weeks
Experimental: Tanezumab 2.5 mg + diclofenac IV tanezumab 2.5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)	Biological: tanezumab IV tanezumab 2.5 mg every 8 weeks (through Week 16) Drug: diclofenac Oral diclofenac SR 75 mg BID for 32 weeks
Placebo Comparator: IV placebo + diclofenac IV placebo to match tanezumab every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)	Drug: diclofenac Oral diclofenac SR 75 mg BID for 32 weeks Other: IV placebo IV placebo to match tanezumab every 8 weeks (through Week 16)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864097

Show 74 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00864097 History of Changes
Other Study ID Numbers:	A4091017
Study First Received:	March 17, 2009
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Arthritis monoclonal antibody nerve growth factor (NGF) anti-NGF tanezumab PF-04383119 RN-624 OA

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics
Diclofenac
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012