Extension Study Of Tanezumab In Osteoarthritis - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00809783

Purpose

Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab

Condition	Intervention	Phase
Osteoarthritis	Biological: tanezumab	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 3, Multicenter, Randomized, Long Term Study Of The Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee Or Hip

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Hematology [ Time Frame: 112 weeks ] [ Designated as safety issue: Yes ]
Electrocardiogram [ Time Frame: 112 weeks ] [ Designated as safety issue: Yes ]
Clinical Chemistry [ Time Frame: 112 weeks ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: 112 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Womac Pain [ Time Frame: 112 weeks ] [ Designated as safety issue: No ]
Womac Physical Function [ Time Frame: 112 weeks ] [ Designated as safety issue: No ]
Womac Stiffness [ Time Frame: 112 weeks ] [ Designated as safety issue: No ]

Enrollment:	2147
Study Start Date:	February 2009
Study Completion Date:	June 2011
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tanezumab 10 mg Tanezumab 10 mg	Biological: tanezumab Tanezumab 10 mg Other Name: RN624
Experimental: Tanezumab 5 mg Tanezumab 5 mg	Biological: tanezumab Tanezumab 5 mg Other Name: RN624
Experimental: Tanezumab 2.5 mg Tanezumab 2.5 mg	Biological: tanezumab Tanezumab 2.5 mg Other Name: RN624

Detailed Description:

This study was terminated on 27 October 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:

Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis

Exclusion Criteria:

Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809783

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:	NCT00809783 History of Changes
Other Study ID Numbers:	A4091016
Study First Received:	December 16, 2008
Last Updated:	November 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Tanezumab OA arthritis

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012