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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01618708
First received: June 11, 2012
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention
Osteoarthritis, Hip
Device: Synvisc-One (hylan G-F 20)
Device: Saline 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 using the patient's assessment of his/her walking pain (WOMAC A1) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in WOMAC A [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Patient Global Self-Assessment (PTGA) of target hip osteoarthritis (OA) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • WOMAC A1 responder rate [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Number of patients reporting treatment-emergent adverse events (AEs) [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment (Group 1)
At Study Day 1 of the treatment period, patients randomized to active treatment (Group 1) will receive an image-guided 6-mL IA injection of Synvisc-One (hylan G-F 20) in the target hip.
Device: Synvisc-One (hylan G-F 20)
6-mL intra-articular (IA) injection
Placebo Comparator: Placebo Control (Group 2)
At Study Day 1 of the treatment period, patients randomized to control (Group 2) will receive an image-guided 6 mL injection of phosphate buffered saline.
Device: Saline Placebo
6 mL injection of phosphate buffered saline

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has symptomatic OA in the target joint
  • The patient has had a diagnosis of primary OA of the hip at Screening according to the American College of Rheumatology (ACR) Criteria
  • The patient, if female and of childbearing potential, must have a negative pregnancy test and have taken oral contraceptives for at least 1 month prior to treatment and continue for the duration of the study (up to and including the final study visit), or agree 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 patient has symptomatic OA in the contralateral hip with a WOMAC A1 NRS score of ≥ 4 at Screening (symptomatic OA with a WOMAC A1 NRS score of 0-3 in the contralateral hip is allowed)
  • The patient if a woman is pregnant, lactating, or unwilling to use adequate contraception
  • The patient had prior viscosupplementation therapy in the target hip joint within 26 weeks of Screening
  • The patient has a known history of hypersensitivity to avian protein or any components of hyaluronan-based injection devices
  • The patient has a known history of hypersensitivity to steroids, lidocaine, and/or acetaminophen
  • The patient has 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 patient has active infection in the area of the injection site
  • The patient has 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 patient used an investigational drug, device or biologic within 12 weeks of Screening
  • The patient has 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

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com
Contact: Medical Information 617-252-7832 medinfo@genzyme.com

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

No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01618708     History of Changes
Other Study ID Numbers: SYNV04910, EFC12791
Study First Received: June 11, 2012
Last Updated: November 21, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014