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 ]

WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) 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.


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