Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
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|ClinicalTrials.gov Identifier: NCT02674386|
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: Investigational Medical Product (IMP) administered in parent study||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT|
|Actual Study Start Date :||August 23, 2016|
|Estimated Primary Completion Date :||August 12, 2019|
|Estimated Study Completion Date :||August 12, 2019|
long-term observational study of subjects from tanezumab parent study
Drug: Investigational Medical Product (IMP) administered in parent study
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.
- Surgeon's Assessment of Procedural Difficulty [ Time Frame: Day of Surgery ]Percentage of surgeries assessed as uneventful, minor complications or major complications.
- Subject's overall satisfaction with surgery as assessed by the Self-Administered Patient Satisfaction (SAPS) Scale [ Time Frame: Week 24 ]Percentage of subjects satisfied vs. unsatisfied with their total joint replacement at Week 24
- Post-surgical complications [ Time Frame: up to Week 24 ]Percentage of subjects with a post-surgical complication(s) up to Week 24.
- Additional or Corrective Procedures [ Time Frame: up to Week 24 ]Percentage of subjects with additional or corrective procedures related to their total joint replacement up to Week 24.
- Physical Rehabilitation Activities [ Time Frame: up to Week 24 ]Percentage of subjects participating in physical rehabilitation activities related to the replaced joint up to Week 24.
- Average Pain [ Time Frame: Change from baseline to Week 24 ]Change from Baseline to Week 24 in average pain in the replaced joint.[Assessed on an 11-point numeric rating scale.]
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Change from baseline to Week 24 ]Change from Baseline to Week 24 in WOMAC Pain, Stiffness and Physical Function subscales in the replaced joint (Subjects undergoing total hip or knee replacement surgery only).
- Shoulder Pain and Disability Index (SPADI) [ Time Frame: Change from baseline to Week 24 ]Change from Baseline to Week 24 in the SPADI in the replaced shoulder (subjects undergoing total shoulder replacement surgery only).
- Concomitant Analgesic Use [ Time Frame: Up to Week 24 ]
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): NCT02674386
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|