Tanezumab in Osteoarthritis of the Hip or Knee - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00985621

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 III

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

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

WOMAC pain [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

WOMAC Pain [ Time Frame: Weeks 2, 4, 8 and 12 ] [ 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% and greater than or equal to 50% [ 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 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: Weeks 2, 4, 8, 12, and 16 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: tanezumab 10 mg tanezumab 10 mg one dose at weeks 0 and 8
2: Experimental	Biological: tanezumab 5 mg tanezumab 5 mg one dose at weeks 0 and 8
3: Active Comparator	Drug: oxycodone oxycodone CR, 10-40 mg q12h
4: Placebo Comparator	Other: placebo placebo

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 35 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, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4091030
Study First Received:	September 25, 2009
Last Updated:	February 5, 2010
ClinicalTrials.gov Identifier:	NCT00985621 History of Changes
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
Joint Diseases
Oxycodone
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Osteoarthritis, Hip
Rheumatic Diseases
Pharmacologic Actions

Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Arthritis
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010