Status:
TERMINATED
The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis
Lead Sponsor:
Daiichi Sankyo
Conditions:
Symptomatic Hip Osteoarthritis
Eligibility:
All Genders
30-80 years
Phase:
PHASE3
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00330135
Start Date
January 1 2005
End Date
March 1 2007
Last Update
January 9 2008
Active Locations (1)
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1
Rueil-Malmaison, France