- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00330135
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Rueil-Malmaison, France
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Sodium hyaluronate 2.5 ml - 1 injection
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Sodium hyaluronate 2.5 ml - 1 injection
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Placebo Comparator: 2
Placebo injection - 1 injection
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placebo injection - 1 injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion)
Time Frame: 3 months
|
3 months
|
WOMAC index (the 3 subscales)
Time Frame: 3 months
|
3 months
|
Consumption of analgesics and NSAIDs
Time Frame: 3 months
|
3 months
|
Evaluation of tolerability (AE reporting)
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xavier Chevalier, Professor, Head of the department of rheumatology Hopital Henri Mondor, Creteil, France
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADA 2003-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Symptomatic Hip Osteoarthritis
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Istituto Ortopedico RizzoliRecruiting
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University of Missouri-ColumbiaEnrolling by invitationSymptomatic Osteochondral Defect(s) | Cartilage, Meniscus, Ankle, Knee, Shoulder, HipUnited States
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
CHU de ReimsCompleted
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Royan InstituteCompletedHip OsteoarthritisIran, Islamic Republic of
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Oxford University Hospitals NHS TrustCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthroplasty | Hip ArthroplastyUnited Kingdom
-
University of ArkansasCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthritis | Hip ArthritisUnited States
-
Johan KarrholmCompletedPrimary Osteoarthritis of Hip Nos | Secondary Osteoarthritis of Hip
-
Istituto Ortopedico RizzoliCompletedHip Osteoarthritis | Arthropathy of HipItaly
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Democritus University of ThraceGeorge Papanicolaou Hospital; Naval Hospital, Athens; Athinaiki General ClinicCompleted
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DiscGenics, Inc.CTI Clinical Trial and Consulting ServicesCompletedDegenerative Disc DiseaseUnited States
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Peking University People's HospitalUnknown
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Second Affiliated Hospital of Xi'an Jiaotong UniversityUnknownDry Eye | Cataract SenileChina
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Ferring PharmaceuticalsCompletedInvestigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the KneeOsteoarthritis of the KneeUnited States
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Laboratorios Sophia S.A de C.V.Completed
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Laboratorios Sophia S.A de C.V.Completed
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Hasanuddin UniversityCompleted
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