Tanezumab In Osteoarthritis Of The Hip Or Knee
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00985621
First received: September 25, 2009
Last updated: August 23, 2012
Last verified: August 2012
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Purpose
The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Biological: tanezumab 10 mg Biological: tanezumab 5 mg Drug: oxycodone Other: placebo |
Phase 3 |
| 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, Placebo- And Oxycodone-Controlled, Multicenter Study Of The Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee Or Hip |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- WOMAC pain [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- WOMAC Pain [ Time Frame: Weeks 2, 4, 12 and 16 ] [ Designated as safety issue: No ]
- WOMAC Physical Function [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
- Patient Global Assessment of Osteoarthritis [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
- OMERACT OARSI responder index [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
- Reduction in the WOMAC Pain subscale of greater than or equal to 30/50/70/90% [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
- Cumulative distribution of percent change from Baseline in the WOMAC Pain subscale score [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- Improvement of ≥2 points in Patient Global Assessment of Osteoarthritis [ Time Frame: Week 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
- Average daily NRS pain score in the index knee or index hip change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
- WOMAC Stiffness subscale change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
- WOMAC Average change from Baseline [ Time Frame: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
- SF-36 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- EQ-5D [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Safety (AEs, laboratory, ECGs, PEs, vital signs, neurological exam) [ Time Frame: All Weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 600 |
| Study Start Date: | October 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: tanezumab 10 mg
tanezumab 10 mg one dose at weeks 0 and 8
|
| Experimental: 2 |
Biological: tanezumab 5 mg
tanezumab 5 mg one dose at weeks 0 and 8
|
| Active Comparator: 3 |
Drug: oxycodone
oxycodone CR, 10-40 mg q12h
|
| Placebo Comparator: 4 |
Other: placebo
placebo
|
Detailed Description:
This study was terminated on 13 Dec 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 to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2
Exclusion Criteria:
- pregnancy or intent to become pregnant
- BMI greater than 39
- other severe pain, significant cardiac, neurological or psychiatric disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985621
Show 99 Study Locations
Show 99 Study LocationsSponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00985621 History of Changes |
| Other Study ID Numbers: | A4091030 |
| Study First Received: | September 25, 2009 |
| Last Updated: | August 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
monoclonal antibody RN624 PF-04383119 nerve growth factor |
OA pain arthritis |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Oxycodone Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 19, 2013