Efficacy and safety assessment of 6 months (24 weeks) treatment with Structum® 500 mg capsule bid in hip osteoarthritis: multicenter randomised double blind parallel group and placebo controlled study. - Not applicable
- Conditions
- Patients with osteoarthritis of the hip.MedDRA version: 7.0Level: LLTClassification code 10048793
- Registration Number
- EUCTR2005-000508-15-SK
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
- Aged from 40 to 75 years,
- Suffering from osteoarthritis of the hip:
- answering to the ACR (American College of Rheumatology) criteria,
- evoluting for more than 6 months,
- with a pain score to the VAS (Visual Analogical Scale) higher than 40,
- with grade II or III of Kellgren and Lawrence classification established from a radiography dated lesser than 6-months,
- Unilateral coxalgia at the inclusion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Haemochromatosis, ochronosis or haemophilia,
- Paget’s disease, chondromatosis or benign synovioma,
- Known symptomatic gonarthrosis homolateral to the hip osteoarthritis,
- Non osteoarthritic pathology, inflammatory, infectious or metabolic arthritis (rheumatoid polyarthritis, ankylosing spondylitis, abarticular rheumatism),
- Symptomatic trochanteric bursitis or acute joint trauma of the target hip,
- Target hip, arthroscopy within the previous year,
- Hip osteoarthritis or other osteoarthritic pathology invalidating and/or that may need surgery during the study period,
- Using or having used NSAID within the past 2 days (including topical treatment near the hip osteoarthritis) or an antalgic drug within the past 12 hours,
- Having used treatment with SYSADOA (Symptomatic Slow-Acting Drugs for Osteoarthritis)within the 3 months prior to study start,
- Having used corticoids (by systemic or local route near the hip osteoarthritis) within the past month,
- Having received an intra-articular injection of corticoids, in the hip within the past 3 months,
- Being asthmatic needing regular or intermittent corticoid treatment,
- Immunodeficient patients or suffering from disease serious or chronic (cardiac, pulmonary, hepatic, renal, haematological, neoplasic or infectious),
- Acute or severe chronic pathology judged by the investigator as serious and incompatible with the study,
- History of pathology which, in the judgement of the investigator, puts them at risk” or is likely to modify their handling of the study results.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of 24-week treatment with Structum® versus placebo on pain at walking in patients suffering from hip osteoarthritis.;Secondary Objective: To evaluate the degree of the functional improvement after 24-week treatment, <br><br>To evaluate the degree of the overall improvement reported by the patient after 24-week treatment, <br><br>To evaluate the degree of the improvement according to the investigator judgment after 24-week treatment,<br><br>To evaluate the antalgic drug consumption (paracetamol and NSAID) during the 24-week treatment duration,<br><br>To evaluate the improvement of the patient quality of life after 24-week treatment,<br><br>To evaluate the clinical tolerance.;Primary end point(s): The main criterion is defined as the mean pain felt during walking: evaluated according to the VAS scale: 0 to 100 after 24-weeks of treatment (comparison between test product (Structum®) and placebo effects).
- Secondary Outcome Measures
Name Time Method