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Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study

Last updated on May 10, 2018

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Study Location
Pfizer Investigational Site
Montgomery, Alabama, 36117 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Arthritis, Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of osteoarthritis (OA) of the knee according to American College of
Rheumatology (ACR) criteria with a Kellgren- Lawrence score of greater than or equal
to 2

- 18 years of age or greater

- Two methods of birth control one of which must be barrier if of childbearing potential

- Willing to discontinue pain medication except as permitted per protocol

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pregnancy or wishing to be pregnant during the course of the study, lactating women

- Body Mass Index (BMI) greater than 39

- Clinically significant cardiac, neurological, psychiatric conditions and other
conditions that are excluded by the protocol.

- Previous exposure to a Nerve Growth Factor (NGF) antibody

NCT01089725
Pfizer
Terminated
Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study

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Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Analgesic Efficacy And Safety Of Subcutaneous Administration Of Tanezumab In Patients With Osteoarthritis Of The Knee
This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.
This study was terminated on 08 Nov 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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Osteoarthritis
  • Arthritis
  • Pain
  • Biological: Placebo IV
    1 ml of placebo administered SC and IV once every 8 weeks.
  • Biological: Placebo SC
    1 ml of placebo administered SC and IV once every 8 weeks.
  • Biological: Tanezumab SC
    1 ml tanezumab injection SC administered every 8 weeks
  • Biological: Placebo IV
    1 ml placebo administered IV every 8 weeks
  • Biological: Placebo IV
    1ml placebo administered IV every 8 weeks
  • Biological: Tanezumab IV
    1 ml tanezumab injection IV administered every 8 weeks
  • Biological: Placebo SC
    1ml placebo administered SC every 8 weeks
  • Placebo Comparator: Placebo
    Interventions:
    • Biological: Placebo IV
    • Biological: Placebo SC
  • Experimental: 2.5 mg tanezumab SC and placebo IV
    Interventions:
    • Biological: Tanezumab SC
    • Biological: Placebo IV
  • Experimental: 5 mg tanezumab SC and placebo IV
    Interventions:
    • Biological: Tanezumab SC
    • Biological: Placebo IV
  • Experimental: 10 mg tanezumab SC and placebo IV
    Interventions:
    • Biological: Tanezumab SC
    • Biological: Placebo IV
  • Experimental: 10 mg tanezumab IV
    Interventions:
    • Biological: Tanezumab IV
    • Biological: Placebo SC
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
385
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of osteoarthritis (OA) of the knee according to American College of Rheumatology (ACR) criteria with a Kellgren- Lawrence score of greater than or equal to 2
  • 18 years of age or greater
  • Two methods of birth control one of which must be barrier if of childbearing potential
  • Willing to discontinue pain medication except as permitted per protocol

Exclusion Criteria:

  • Pregnancy or wishing to be pregnant during the course of the study, lactating women
  • Body Mass Index (BMI) greater than 39
  • Clinically significant cardiac, neurological, psychiatric conditions and other conditions that are excluded by the protocol.
  • Previous exposure to a Nerve Growth Factor (NGF) antibody
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01089725
A4091027
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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