Last updated date
ABOUT THIS STUDY
Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in
patients with osteoarthritis
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Osteoarthritis
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2
Exclusion Criteria
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- pregnancy or intent to become pregnant
- BMI greater than 39
- other severe pain, significant cardiac, neurological or psychiatric disease
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Tanezumab in Osteoarthritis of the Hip or Knee (2) | |||
Official Title ICMJE | A Phase 3 Randomized, Double Blind Placebo And Naproxen Controlled Multicenter Study of the Analgesic Efficacy And Study of Tanezumab in Patients With Osteoarthritis Of The Hip or Knee | |||
Brief Summary | Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Osteoarthritis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 849 | |||
Original Estimated Enrollment ICMJE | 800 | |||
Actual Study Completion Date ICMJE | June 2010 | |||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00863304 | |||
Other Study ID Numbers ICMJE | A4091018 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |