The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis
This study has been terminated.
Sponsor:
Sankyo Pharma France
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00330135
First received: May 23, 2006
Last updated: January 7, 2008
Last verified: January 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Symptomatic Hip Osteoarthritis |
Drug: Sodium hyaluronate Drug: placebo injection |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 85 |
| Study Start Date: | January 2005 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330135
Locations
| France | |
| Rueil-Malmaison, France | |
Sponsors and Collaborators
Sankyo Pharma France
Investigators
| Principal Investigator: | Xavier Chevalier, Professor | Head of the department of rheumatology Hopital Henri Mondor, Creteil, France |
More Information
No publications provided by Daiichi Sankyo Inc.
Additional 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 |
| Study First Received: | May 23, 2006 |
| Last Updated: | January 7, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Daiichi Sankyo Inc.:
|
hip osteoarthritis Hyaluronic acid Viscosupplementation intra-articular injections |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013