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Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01127893
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : May 21, 2010
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
An evaluation of the long term safety of tanezumab when administered by subcutaneous injection every 8 weeks for up to 64 weeks

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

Detailed Description:
This study was terminated on 29 September 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 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 The Subcutaneous Administration Of Tanezumab In Patients With Osteoarthritis Of The Knee
Study Start Date : June 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Tanezumab 10 mg Biological: Tanezumab
Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for up to 7 injections

Experimental: Tanezumab 5 mg Biological: Tanezumab
Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections

Experimental: Tanezumab 2.5 mg Biological: Tanezumab
Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections




Primary Outcome Measures :
  1. Hematology [ Time Frame: 64 weeks ]
  2. Electrocardiogram [ Time Frame: 64 weeks ]
  3. Clinical Chemistry [ Time Frame: 64 weeks ]
  4. Adverse Events [ Time Frame: 64 weeks ]

Secondary Outcome Measures :
  1. The Western Ontario MacMaster (WOMAC) questionnaire Pain [ Time Frame: 64 weeks ]
  2. WOMAC Physical Function [ Time Frame: 64 weeks ]
  3. WOMAC Stiffness [ Time Frame: 64 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have participated in specific Phase 3 parent study

Exclusion Criteria:

  • Failed screening for parent study, pregnant women, lactating mothers

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): NCT01127893


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01127893    
Other Study ID Numbers: A4091032
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Keywords provided by Pfizer:
Musculoskeletal Diseases
Joint Diseases
Arthritis
Rheumatic Diseases
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tanezumab
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs