The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

January 7, 2008 updated by: Daiichi Sankyo, Inc.

Multicentre, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rueil-Malmaison, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Primary osteoarthritis of the hip defined according to the ACR criteria; symptomatic, 2. Osteoarthritis of radiological grade II to III according to the Kellgren-Lawrence classification, using X-rays performed during the last three months, 3. Overall pain intensity between 40 and 80 mm on a VAS of 100 mm at the pre-screening examination, 4. The patients experienced pain at least one in two days during the last 30 days, it was resistant to paracetamol treatment at a dose of 4 g/day and a step 2 analgesic or a NSAID taken for at least 10 days, 5. A prosthesis is not planned in the next six months.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception,
  • Major dysplasia (defined using Lequesne's criteria as dislocation of the hip),
  • Treatment by intra-articular injection of hyaluronic acid in the symptomatic hip during the 6 months prior to pre-screening,
  • Patients with a history of hypersensitivity to any of the ingredients in the hyaluronan,
  • The presence of inflammatory arthropathy or another disorder or condition that could affect the joint (e.g., rheumatoid arthritis, metabolic bone disease, femoral head necrosis, psoriasis, gout, infection),
  • Another muscular or skeletal condition that could interfere with the evaluation of the efficacy of the treatment on the hip in question (evaluation of pain or functional handicap),
  • Systemic corticosteroid therapy or intra-articular injection of corticosteroids into the ipsilateral hip or knee within the last month,
  • Intermittent claudication or vascular disease,
  • Previous surgery on the hip in question,
  • Septic arthritis at any site,
  • Any surgical procedure, including arthroplasty or arthroscopy, to the hip during the six months prior to pre-screening or surgery scheduled during the trial,
  • Any chronic skin condition that could affect the site of the injection,
  • Use of the investigational treatment or material during the last three months,
  • Oral or injectable anticoagulant treatment,
  • Antiaggregant platelet treatment, particularly low-dose aspirin,
  • Symptomatic chondrocalcinosis in the painful hip

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Sodium hyaluronate 2.5 ml - 1 injection
Drug: Sodium hyaluronate
Sodium hyaluronate 2.5 ml - 1 injection
Placebo Comparator: 2
Placebo injection - 1 injection
Drug: placebo injection
placebo injection - 1 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in overall pain, 3 months after a single intra-articular injection. The intensity of the pain will be evaluated using a continuous VAS of 100 mm of the overall level of pain in the affected hip.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion)
Time Frame: 3 months
3 months
WOMAC index (the 3 subscales)
Time Frame: 3 months
3 months
Consumption of analgesics and NSAIDs
Time Frame: 3 months
3 months
Evaluation of tolerability (AE reporting)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Investigators

  • Principal Investigator: Xavier Chevalier, Professor, Head of the department of rheumatology Hopital Henri Mondor, Creteil, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

May 23, 2006

First Submitted That Met QC Criteria

May 23, 2006

First Posted (Estimate)

May 25, 2006

Study Record Updates

Last Update Posted (Estimate)

January 9, 2008

Last Update Submitted That Met QC Criteria

January 7, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADA 2003-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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