Tanezumab in Osteoarthritis of the Hip or Knee
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: tanezumab 10 mg (Biological); tanezumab 5 mg (Biological); oxycodone (Drug); placebo (Other)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared
to oxycodone CR and placebo in patients with osteoarthritis.
Clinical Details
Official title: A Phase 3 Randomized, Double-Blind, Placebo- and Oxycodone-Controlled, Multicenter Study of the Efficacy and Safety of Tanezumab in Patients With Osteoarthritis of the Knee or Hip
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: WOMAC pain
Secondary outcome: WOMAC PainWOMAC Physical Function Patient Global Assessment of Osteoarthritis OMERACT OARSI responder index Reduction in the WOMAC Pain subscale of greater than or equal to 30% and greater than or equal to 50% Cumulative distribution of percent change from Baseline in the WOMAC Pain subscale score Improvement of ≥2 points in Patient Global Assessment of Osteoarthritis Average daily NRS pain score in the index knee or index hip change from Baseline WOMAC Stiffness subscale change from Baseline WOMAC Average change from Baseline SF-36 EQ-5D Safety (AEs, laboratory, ECGs, PEs, vital signs, neurological exam)
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2
Exclusion Criteria:
- pregnancy or intent to become pregnant
- BMI greater than 39
- other severe pain, significant cardiac, neurological or psychiatric disease
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2009
Ending date: October 2010
Last updated: September 25, 2009
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