MedTrace Logo

The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

NCT00330135 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2008-01-09

No results posted yet for this study

Summary

To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip.

Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic hip and will be followed up for three months.

At the third month, if the score for overall pain is still \> 40 mm on the VAS, a second injection of ADANT® can be given irrespective of which treatment was received previously. The patient will be followed up for a further 3 months in an open-label fashion (monthly visits).

Conditions

  • Symptomatic Hip Osteoarthritis

Interventions

DRUG

Sodium hyaluronate

Sodium hyaluronate 2.5 ml - 1 injection

DRUG

placebo injection

placebo injection - 1 injection

Sponsors & Collaborators

Principal Investigators

  • Xavier Chevalier, Professor · Head of the department of rheumatology Hopital Henri Mondor, Creteil, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

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 NCT00330135 on ClinicalTrials.gov