Trials Sponsors Conditions Drugs Pricing

Conditions

Musculoskeletal Diseases Osteoarthritis, Knee

Keywords

Osteoarthritis of the kneeMusculoskeletal

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale
The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.
Day 0, up to week 26

Secondary Outcomes (7)

Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale
Day 0, Week 26
Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale
Week 26
Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale
Day 0, up to week 26
Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale
Day 0, Week 26
Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26
Week 26

Study Arms (2)

Synvisc

EXPERIMENTAL

Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc).

Device: hylan G-F 20

Saline Control

PLACEBO COMPARATOR

Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.

Other: Phosphate Buffered Saline

Interventions

hylan G-F 20Device

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

Also known as: Synvisc-One

Synvisc

Phosphate Buffered SalineOther

Single injection of 6 mL phosphate buffered saline.

Saline Control

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient with documented diagnosis of primary osteoarthritis (OA) of the target knee made at least 3 months prior to Screening,
Has radiographic evidence of OA in the tibio-femoral compartment of the target, knee with at least 1 definite osteophyte and a measureable joint space, as diagnosed by standard X-rays taken not longer than 3 months prior to Screening, and before any baseline assessment,

Sponsors & Collaborators

Genzyme, a Sanofi Company
Industrylead

Study Sites (21)

Hopital Erasme

Brussels, 1070, Belgium

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Universitair Ziekenhuis Gastuisberg Leuven

Leuven, 3000, Belgium

CHU Liege

Liège, 4000, Belgium

Faculty Hospital Bohunice

Brno, 62500, Czechia

Institute of Rheumatology

Prague, 12850, Czechia

Faculty Thomayer Hospital

Prague, 14059, Czechia

Related Publications (1)

Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, Bailleul F, Pavelka K. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis. 2010 Jan;69(1):113-9. doi: 10.1136/ard.2008.094623.
PMID: 19304567DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesRheumatic Diseases

Results Point of Contact

Title: Genzyme Medical Information
Organization: Genzyme Corporation

Study Officials

Medical Monitor
Genzyme, a Sanofi Company
STUDY DIRECTOR

Publication Agreements

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

Enrollment

253 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 18, 2005

Study Start

May 2005

Date type not reported

This date has not been verified as actual or estimated.

A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Synvisc

Saline Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Synvisc

Saline Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations