Patients with osteoarthritis of the hip MedDRA version: 7.0 Level: LLT Classification code 10048793
Conditions
Interventions
Trade Name: STRUCTUM 500 mg gélule
Product Name: STRUCTUM 500 mg capsule
Product Code: L0023 GE
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sodium chondroitin sulphate
Current Sponsor code
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - Haemochromatosis, ochronosis or haemophilia, - Paget’s disease, chondromatosis or benign synovioma, - Known symptomatic gonarthrosis homolateral to the hip osteoarthritis, - Non osteoartritic 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, To evaluate the degree of the overall improvement reported by the patient after 24-week treatment, To evaluate the degree of the improvement according to the investigator judgment after 24-week treatment, To evaluate the antalgic drug consumption (paracetamol and NSAID) during the 24-week treatment duration, To evaluate the improvement of the patient quality of life after 24-week treatment, 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). | — |
Countries
Czech Republic, Slovakia
Outcome results
None listed