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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sodium hyaluronate 2.5 ml - 1 injection |
|
| 2 | Placebo Comparator | Placebo injection - 1 injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium hyaluronate | Drug | Sodium hyaluronate 2.5 ml - 1 injection |
| |
| Measure | Description | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion) | 3 months | |
| WOMAC index (the 3 subscales) | 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Chevalier, Professor | Head of the department of rheumatology Hopital Henri Mondor, Creteil, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rueil-Malmaison | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19248105 | Derived | Richette P, Ravaud P, Conrozier T, Euller-Ziegler L, Mazieres 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. doi: 10.1002/art.24301. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| placebo injection |
| Drug |
placebo injection - 1 injection |
|
| Consumption of analgesics and NSAIDs |
| 3 months |
| Evaluation of tolerability (AE reporting) | 3 months |
| D012216 |
| Rheumatic Diseases |