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Extension Study Of Tanezumab In Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00809783
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : December 17, 2008
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: tanezumab Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2009
Primary Completion Date : October 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Hematology [ Time Frame: 112 weeks ]
  2. Electrocardiogram [ Time Frame: 112 weeks ]
  3. Clinical Chemistry [ Time Frame: 112 weeks ]
  4. Adverse Events [ Time Frame: 112 weeks ]

Secondary Outcome Measures :
  1. Womac Pain [ Time Frame: 112 weeks ]
  2. Womac Physical Function [ Time Frame: 112 weeks ]
  3. Womac Stiffness [ Time Frame: 112 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809783


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00809783     History of Changes
Other Study ID Numbers: A4091016
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: November 7, 2011
Last Verified: November 2011

Keywords provided by Pfizer:
Tanezumab OA arthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases