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

NCT01618708 | Completed Results

• 2 other identifiers: SYNV04910EFC12791
• Study Type: interventional
• Target: 357
• Locations: 2 countries
• Sites: 48

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.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks

  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.

  From baseline to Week 26

Secondary Outcomes (3)

• Change From Baseline in WOMAC A Score Over 26 Weeks

  From Baseline to Week 26

• Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks

  From baseline to Week 26

• Percentage of WOMAC A1 Responder Over 26 Weeks

  From Baseline to Week 26

Study Arms (2)

Synvisc-One

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

Single IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.

Device: Placebo

Interventions

Synvisc-One (hylan G-F 20) DEVICE

6-mL IA injection

Synvisc-One

Placebo DEVICE

6 mL injection of phosphate buffered saline

Placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (48)

Investigational Site Number 840025

Burmingham, Alabama, 35216, United States

Location

Investigational Site Number 840042

Phoenix, Arizona, 85016, United States

Location

Investigational Site Number 840056

Phoenix, Arizona, 85027, United States

Location

Investigational Site Number 840004

Tucson, Arizona, 85712, United States

Location

Investigational Site Number 840023

Covina, California, 91723, United States

Location

Investigational Site Number 840058

La Mesa, California, 91942, United States

Location

Investigational Site Number 840022

Santa Monica, California, 90904, United States

Location

Investigational Site Number 840050

Farmington, Connecticut, 06033, United States

Location

Investigational Site Number 840027

Stamford, Connecticut, 06905, United States

Location

Investigational Site Number 840051

Waterbury, Connecticut, 06708, United States

Location

Investigational Site Number 840011

Bradenton, Florida, 84020, United States

Location

Investigational Site Number 840036

Fort Lauderdale, Florida, 33316, United States

Location

Investigational Site Number 840017

Jupiter, Florida, 33458, United States

Location

Investigational Site Number 840038

New Port Richey, Florida, 34652, United States

Location

Investigational Site Number 840041

Pensacola, Florida, 32504, United States

Location

Investigational Site Number 840047

Sarasota, Florida, 34232, United States

Location

Investigational Site Number 840049

South Miami, Florida, 33134, United States

Location

Investigational Site Number 840039

Marietta, Georgia, 30060, United States

Location

Investigational Site Number 840005

Meridian, Idaho, 83642, United States

Location

Investigational Site Number 840002

Chicago, Illinois, 60611, United States

Location

Investigational Site Number 840043

Wichita, Kansas, 67203, United States

Location

Investigational Site Number 840012

Lexington, Kentucky, 40509, United States

Location

Investigational Site Number 840033

Traverse City, Michigan, 49648, United States

Location

Investigational Site Number 840037

St Louis, Missouri, 63128, United States

Location

Investigational Site Number 840007

Reno, Nevada, 89502, United States

Location

Investigational Site Number 840048

Egg Harbor, New Jersey, 08234, United States

Location

Investigational Site Number 840024

Amherst, New York, 14226, United States

Location

Investigational Site Number 840029

Hartsdale, New York, 10530, United States

Location

Investigational Site Number 840014

Rochester, New York, 14609, United States

Location

Investigational Site Number 840044

Asheville, North Carolina, 28801, United States

Location

Investigational Site Number 840028

Raleigh, North Carolina, 27612, United States

Location

Investigational Site Number 840045

Wilmington, North Carolina, 28401, United States

Location

Investigational Site Number 840046

Columbus, Ohio, 43213, United States

Location

Investigational Site Number 840013

Altoona, Pennsylvania, 16635, United States

Location

Investigational Site Number 840055

Philadelphia, Pennsylvania, 19107, United States

Location

Investigational Site Number 840018

Reading, Pennsylvania, 19611, United States

Location

Investigational Site Number 840026

Mt. Pleasant, South Carolina, 29464, United States

Location

Investigational Site Number 840052

Memphis, Tennessee, 38163, United States

Location

Investigational Site Number 840054

Austin, Texas, 78751, United States

Location

Investigational Site Number 840040

Bedford, Texas, 76021, United States

Location

Investigational Site Number 840010

Dallas, Texas, 75235, United States

Location

Investigational Site Number 840009

Draper, Utah, 84020, United States

Location

Investigational Site Number 840032

Salt Lake City, Utah, 84107, United States

Location

Investigational Site Number 840016

Charlottesville, Virginia, 22901, United States

Location

Investigational Site Number 840003

Seattle, Washington, 98166, United States

Location

Investigational Site Number 124091

London, N6C 4R3, Canada

Location

Investigational Site Number 124093

Montreal, H4N 3C5, Canada

Location

Investigational Site Number 124092

Sherbrooke, J1H 1Z1, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-05

Locations

CA (3); US (45)