The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00330135
• Date of registration: 23/05/2006
• Prospective Registration: No
• Primary sponsor: Sankyo Pharma France
• Public title: The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis
• Scientific title: Multicentre, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis
• Date of first enrolment: January 2005
• Target sample size: 85
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00330135
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

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

Key inclusion & exclusion criteria

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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Symptomatic Hip Osteoarthritis

Intervention(s)

Drug: placebo injection

Drug: Sodium hyaluronate

Primary Outcome(s)

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(s)

Evaluation of tolerability (AE reporting) [Time Frame: 3 months]

Consumption of analgesics and NSAIDs [Time Frame: 3 months]

Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion) [Time Frame: 3 months]

WOMAC index (the 3 subscales) [Time Frame: 3 months]

Secondary ID(s)

ADA 2003-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors