The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

NCT00330135 | Terminated Phase 3

• 1 other identifier: ADA 2003-01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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).

Conditions

Symptomatic Hip Osteoarthritis

Keywords

hip osteoarthritis; Hyaluronic acid; Viscosupplementation; intra-articular injections

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion)

  3 months

• WOMAC index (the 3 subscales)

  3 months

• Consumption of analgesics and NSAIDs

  3 months

• Evaluation of tolerability (AE reporting)

  3 months

Study Arms (2)

1

EXPERIMENTAL

Sodium hyaluronate 2.5 ml - 1 injection

Drug: Sodium hyaluronate

2

PLACEBO COMPARATOR

Placebo injection - 1 injection

Drug: placebo injection

Interventions

Sodium hyaluronate DRUG

Sodium hyaluronate 2.5 ml - 1 injection

1

placebo injection DRUG

placebo injection - 1 injection

2

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

Unknown Facility

Rueil-Malmaison, France

Location

Related Publications (1)

• 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.

  PMID: 19248105 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Xavier Chevalier, Professor

  Head of the department of rheumatology Hopital Henri Mondor, Creteil, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 23, 2006
• First Posted: May 25, 2006
• Study Start: January 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: January 9, 2008

Record last verified: 2008-01

Locations

FR (1)