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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

NCT01618708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2016-07-11

Study results available
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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

Interventions

DEVICE

Synvisc-One (hylan G-F 20)

6-mL IA injection

DEVICE

Placebo

6 mL injection of phosphate buffered saline

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01618708 on ClinicalTrials.gov