CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 253 enrolled
Drug / intervention
hylan G-F 20 +1 moredevice
Likely dose
Single injection of 6 mL of hylan G-F 20 (Synvisc)AI-extracted
Key inclusion· 5
  • ✓Documented diagnosis of primary osteoarthritis of the target knee made at least 3 months prior to screening.
  • ✓Radiographic evidence of OA in the tibio-femoral compartment with at least 1 definite osteophyte and measurable joint space on X-rays taken ≤3 months prior to screening.
  • ✓Continued target knee pain despite conservative treatment (weight reduction, physical therapy, analgesics).
  • ✓Pain in target knee: WOMAC LK 3.1 A1 (Walking Pain) subscale score of 2 or 3.
Key exclusion· 6
  • ✕Kellgren-Lawrence grade IV OA in the patello-femoral compartment of the target knee.
  • ✕Clinically apparent tense effusion of the target knee.
  • ✕Viscosupplementation in any joint including target knee within 9 months prior to screening.
  • ✕Concomitant inflammatory disease or condition affecting joints (rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis, active infection).

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00131352
NCT00131352Phase 3Completed
CompareCT.gov

A Multi-Centre, Parallel, Double-Blind, Blinded Evaluator, Randomised, Placebo-Controlled Evaluation of the Efficacy and Safety of a Single Dose of 6 mL of Synvisc in Patients With Symptomatic Osteoarthritis of the Knee

Genzyme, a Sanofi Company·interventional·Posted Aug 18, 2005·Updated Apr 3, 2015

In Brief

A Phase 3 clinical trial evaluating hylan G-F 20 and Phosphate Buffered Saline for Osteoarthritis, Knee and Musculoskeletal Diseases. Completed, enrolled 253 participants across 21 sites in 6 countries.

Detailed Summary

This clinical study is to evaluate the safety and efficacy of hylan G-F 20 (Synvisc) in patients with symptomatic knee osteoarthritis (OA). Patients will be given 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control), with a possible repeat treatment with Synvisc after the week 26 visit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee, Musculoskeletal Diseases
CountriesBelgium, Czechia, France, Germany, Netherlands, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 18, 2005
Enrollment StartMay 1, 2005
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.9 years ago

Interventions

hylan G-F 20device

Single injection of 6 mL of hylan G-F 20 (Synvisc).

Phosphate Buffered Salineother

Single injection of 6 mL phosphate buffered saline.