A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip

Overview

The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 2015

Interventions

  • Device: Synvisc-One (hylan G-F 20)
    • 6-mL IA injection
  • Device: Placebo
    • 6 mL injection of phosphate buffered saline

Arms, Groups and Cohorts

  • Experimental: Synvisc-One
    • Single intraarticular (IA) injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
  • Placebo Comparator: Placebo
    • Single IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • The participant had symptomatic osteoarthritis (OA) in the target joint – The participant had a diagnosis of primary OA of the hip at Screening according to the American College of Rheumatology (ACR) Criteria – The participant, if female and of childbearing potential, must had a negative pregnancy test and had taken oral contraceptives for at least 1 month prior to treatment and continued for the duration of the study (up to and including the final study visit), or agreed to use 2 forms of contraception (e.g., condoms plus spermatocide), otherwise females must be surgically sterile, or postmenopausal for at least 1 year Exclusion Criteria:

  • The participant had symptomatic OA in the contralateral hip with a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 numerical rating scale (NRS) score of ≥ 4 at Screening (symptomatic OA with a WOMAC A1 NRS score of 0-3 in the contralateral hip was allowed) – The participant if a woman was pregnant, lactating, or unwilling to use adequate contraception – The participant had prior viscosupplementation therapy in the target hip joint within 26 weeks of Screening – The participant had a known history of hypersensitivity to avian protein or any components of hyaluronan-based injection devices – The participant had a known history of hypersensitivity to steroids, lidocaine, and/or acetaminophen – The participant had a known history of hypersensitivity to injected contrast agent at a previous radiological examination (e.g., computed tomography [CT] scan, angiogram, etc.), or known history of hypersensitivity to shellfish or iodine, or any other impediment to the hip injection procedure – The participant had active infection in the area of the injection site – The participant had any major surgery, arthroplasty or arthroscopy in the target hip or lower extremities within 26 weeks of Screening, or planned surgery in the lower extremities throughout the duration of the study infectious complications – The participant used an investigational drug, device or biologic within 12 weeks of Screening – The participant had any significant medical condition that the Investigator feels would interfere with study evaluations and study participation

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Genzyme, a Sanofi Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Genzyme, a Sanofi Company

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