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The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00330135
Recruitment Status : Terminated
First Posted : May 25, 2006
Last Update Posted : January 9, 2008
Information provided by:
Daiichi Sankyo, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Symptomatic Hip Osteoarthritis Drug: Sodium hyaluronate Drug: placebo injection Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis
Study Start Date : January 2005
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion) [ Time Frame: 3 months ]
  2. WOMAC index (the 3 subscales) [ Time Frame: 3 months ]
  3. Consumption of analgesics and NSAIDs [ Time Frame: 3 months ]
  4. Evaluation of tolerability (AE reporting) [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330135

Rueil-Malmaison, France
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Principal Investigator: Xavier Chevalier, Professor Head of the department of rheumatology Hopital Henri Mondor, Creteil, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine Koch, Daiichi Sankyo France
ClinicalTrials.gov Identifier: NCT00330135     History of Changes
Other Study ID Numbers: ADA 2003-01
First Posted: May 25, 2006    Key Record Dates
Last Update Posted: January 9, 2008
Last Verified: January 2008

Keywords provided by Daiichi Sankyo, Inc.:
hip osteoarthritis
Hyaluronic acid
intra-articular injections

Additional relevant MeSH terms:
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents