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The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

Primary Purpose

Symptomatic Hip Osteoarthritis

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Sodium hyaluronate
placebo injection
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Hip Osteoarthritis focused on measuring hip osteoarthritis, Hyaluronic acid, Viscosupplementation, intra-articular injections

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Sodium hyaluronate 2.5 ml - 1 injection

Placebo injection - 1 injection

Outcomes

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.

Secondary Outcome Measures

Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion)
WOMAC index (the 3 subscales)
Consumption of analgesics and NSAIDs
Evaluation of tolerability (AE reporting)

Full Information

First Posted
May 23, 2006
Last Updated
January 7, 2008
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00330135
Brief Title
The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis
Official Title
Multicentre, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Terminated
Study Start Date
January 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Hip Osteoarthritis
Keywords
hip osteoarthritis, Hyaluronic acid, Viscosupplementation, intra-articular injections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Sodium hyaluronate 2.5 ml - 1 injection
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo injection - 1 injection
Intervention Type
Drug
Intervention Name(s)
Sodium hyaluronate
Intervention Description
Sodium hyaluronate 2.5 ml - 1 injection
Intervention Type
Drug
Intervention Name(s)
placebo injection
Intervention Description
placebo injection - 1 injection
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion)
Time Frame
3 months
Title
WOMAC index (the 3 subscales)
Time Frame
3 months
Title
Consumption of analgesics and NSAIDs
Time Frame
3 months
Title
Evaluation of tolerability (AE reporting)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Chevalier, Professor
Organizational Affiliation
Head of the department of rheumatology Hopital Henri Mondor, Creteil, France
Official's Role
Principal Investigator
Facility Information:
City
Rueil-Malmaison
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19248105
Citation
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.
Results Reference
derived

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The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

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