Clinical Trial: A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pivotal, Multicenter, Double Blind Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Mild to Moderate Primary Osteoarthritis of the Hip
Brief Summary: The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.
Detailed Summary:
Sponsor: Genzyme, a Sanofi Company
Current Primary Outcome: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks [ Time Frame: From baseline to Week 26 ]
Original Primary Outcome: Change from Baseline using the patient's assessment of his/her walking pain (WOMAC A1) [ Time Frame: 26 weeks ]
Current Secondary Outcome:
- Change From Baseline in WOMAC A Score Over 26 Weeks [ Time Frame: From Baseline to Week 26 ]WOMAC NRS 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) was measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.
- Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks [ Time Frame: From baseline to Week 26 ]PTGA (self-assessment of target hip osteoarthritis condition) was measured using the 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents very well condition and higher score represents very poor condition.
- Percentage of WOMAC A1 Responder Over 26 Weeks [ Time Frame: From Baseline to Week 26 ]WOMAC A1 responder rate defined as ≥2 point improvement on 11-point NRS Scale, generalized estimating equations modeling was used for the analysis of WOMAC A1 responders.
Original Secondary Outcome:
- Change from Baseline in WOMAC A [ Time Frame: 26 weeks ]
- Change from Baseline in Patient Global Self-Assessment (PTGA) of target hip osteoarthritis (OA) [ Time Frame: 26 weeks ]
- WOMAC A1 responder rate [ Time Frame: 26 weeks ]
- Number of patients reporting treatment-emergent adverse events (AEs) [ Time Frame: 26 weeks ]
Information By: Sanofi
Dates:
Date Received: June 11, 2012
Date Started: September 2012
Date Completion:
Last Updated: May 31, 2016
Last Verified: May 2016