Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

This study has been terminated.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00330135
First received: May 23, 2006
Last updated: January 7, 2008
Last verified: January 2008

May 23, 2006
January 7, 2008
January 2005
March 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
  • 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 irrespective of the circumstances of the previous 48 hours.
Complete list of historical versions of study NCT00330135 on ClinicalTrials.gov Archive Site
  • Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • WOMAC index (the 3 subscales) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Consumption of analgesics and NSAIDs [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Evaluation of tolerability (AE reporting) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion)
  • WOMAC index (the 3 subscales)
  • Consumption of analgesics and NSAIDs
  • Evaluation of tolerability (AE reporting)
Not Provided
Not Provided
 
The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Symptomatic Hip Osteoarthritis
  • Drug: Sodium hyaluronate
    Sodium hyaluronate 2.5 ml - 1 injection
  • Drug: placebo injection
    placebo injection - 1 injection
  • Experimental: 1
    Sodium hyaluronate 2.5 ml - 1 injection
    Intervention: Drug: Sodium hyaluronate
  • Placebo Comparator: 2
    Placebo injection - 1 injection
    Intervention: Drug: placebo injection
Richette P, Ravaud P, Conrozier T, Euller-Ziegler L, Mazières B, Maugars Y, Mulleman D, Clerson P, Chevalier X. Effect of hyaluronic acid in symptomatic hip osteoarthritis: a multicenter, randomized, placebo-controlled trial. Arthritis Rheum. 2009 Mar;60(3):824-30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
85
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00330135
ADA 2003-01
No
Catherine Koch, Daiichi Sankyo France
Sankyo Pharma France
Not Provided
Principal Investigator: Xavier Chevalier, Professor Head of the department of rheumatology Hopital Henri Mondor, Creteil, France
Daiichi Sankyo Inc.
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP