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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01618708
First received: June 11, 2012
Last updated: May 31, 2016
Last verified: May 2016
  Purpose
The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.

Condition Intervention
Osteoarthritis, Hip
Device: Synvisc-One (hylan G-F 20)
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change From Baseline in WOMAC A Score Over 26 Weeks [ Time Frame: From Baseline to Week 26 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 357
Study Start Date: September 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Synvisc-One (hylan G-F 20)
6-mL IA injection
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.
Device: Placebo
6 mL injection of phosphate buffered saline

  Eligibility

Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618708

  Show 48 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01618708     History of Changes
Other Study ID Numbers: SYNV04910  EFC12791 
Study First Received: June 11, 2012
Results First Received: May 31, 2016
Last Updated: May 31, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hylan
Hyaluronic Acid
Viscosupplements
Protective Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on July 24, 2016