Comparative study of efficacy and safety of Structum® and Chondrosulf® in patients with symptomatic osteoarthritis of the knee.A Multicenter, Randomized, Double-Blind, Double Placebo-Controlled, Parallel Group Study

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2008-000871-19-FR
• Date of registration: 18/03/2008
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Médicament
• Public title: Comparative study of efficacy and safety of Structum® and Chondrosulf® in patients with symptomatic osteoarthritis of the knee.A Multicenter, Randomized, Double-Blind, Double Placebo-Controlled, Parallel Group Study
• Scientific title: Comparative study of efficacy and safety of Structum® and Chondrosulf® in patients with symptomatic osteoarthritis of the knee.A Multicenter, Randomized, Double-Blind, Double Placebo-Controlled, Parallel Group Study
• Date of first enrolment: 10/04/2008
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000871-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: double placebo controlled; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion criteria:
To be included in the trial, patients should fulfill the following criteria:
-male or female between 50 and 80 years of age,
-presenting with medial and/or lateral femorotibial OA of the knee fulfilling ACR criteria (knee pain + crepitus + morning stiffness < 30 minutes),
+evolving for more than 6 months,
+with a global pain score greater than or equal to 40 on a 100mm VAS,
+with Lequesne Index greater than or equal to 7,
+with a grade II or III according to the Kellgren and Lawrence radiological classification, on an antero-posterior weight-bearing X-ray image of both knees taken within the 12 months preceding inclusion,
-having given their written consent to take part in the study,
-covered by social security or a health insurance policy
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:
Patients fulfilling at least one of the following criteria cannot be included in the study:
- Disease-related criteria:
-isolated symptomatic femoropatellar osteoarthritis of the knee,
-hemochromatosis, ochronosis or hemophilia,
-Paget's disease of bone, chondromatosis or villonodular synovitis,
-symptomatic hip OA homolateral to the target knee,
-inflammatory, infectious or metabolic arthritis (rheumatoid arthritis, ankylosing spondylitis, abarticular rheumatism…),
-Anticipated surgery of the knee during the course of the study.
- Previous or concomitant treatment-related criteria:
-patient taking a symptomatic slow-acting drug for OA (SYSADOA) or a dietary supplement containing glucosamine, chondroitin sulfate, diacerhein or avocado-soybeans extracts in the 3 months preceding inclusion,
-patient taking bisphosphonates or strontium ranelate in the 3 months preceding inclusion,
-patient having received corticosteroid treatment by any administration route during the month preceding inclusion,
-patient having received intra-articular steroid injection in the target knee in the 2 months preceding inclusion or patient having received intra-articular hyaluronic acid in the target knee in the 6 months preceding inclusion,
-patient having taken NSAIDs in the 2 days preceding inclusion (including topical application surrounding the target knee) or paracetamol in the 12 hours preceding inclusion,
-patient having undergone surgery (osteotomy, extra-articular ligamentoplasty, knee replacement, etc.) on the target knee,
-patient having undergone articular lavage of target knee in the 3 months preceding inclusion,
-patient having experienced physiotherapy, reeducation, alternative medicine (mesotherapy, acupuncture) throughout the whole treatment period,
-patient with a known allergy to the study medication or one of its constituents,
-patient requiring regular or intermittent steroid therapy.
- Patient-related criteria:
-important genu varum or valgum > 8° (physiological angle including),
-Body mass index (BMI) greater than or equal to 34,
-immunocompromised patient or patient presenting with a serious or progressive disease (cardiac, pulmonary, hepatic, renal, hematological, neoplastic or infectious disease),
-patient presenting with a severe acute or chronic disease which the investigator deems incompatible with study implementation,
-patient presenting with a disease which the investigator considers likely to interfere with the study results or to expose the patient to additional risk,
-patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion,
-patient having taken part in a clinical trial in the preceding 30 days or taking part in a trial at the time of inclusion,
-patient linguistically or psychologically unable to understand and sign the consent form,
-For women:
+pregnant, breast feeding or likely to become pregnant during the time of the study
+women with childbearing potential not using effective contraception (oral contraceptives, intrauterine device, tubal ligation or other efficient procedures),
- Rescue medication-related criteria:
-patient with hypersensitivity to acetaminophen / paracetamol


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Symptomatic Knee osteoarthritis
MedDRA version: 9.1 Level: LLT Classification code 10031165 Term: Osteoarthritis knee

Intervention(s)

Trade Name: Structum
Product Name: Structum
Product Code: L0023 GE
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Chondroïtine sulfate sodique
CAS Number: 9082-07-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Chondrosulf
Product Name: Chondrosulf
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Chondritin sulfate sodium
CAS Number: 9082-07-09
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Comparison between the L0023 and Reference groups of the mean variation of global pain score and Lequesne Index over 24 weeks

Main Objective: To demonstrate non-inferiority of Structum® to Chondrosulf® on pain relief and functional improvement in patients with symptomatic knee OA over 24 weeks.

Secondary Objective: To compare the efficacy of Structum® and Chondrosulf® on :
-Patient’s and investigator’s global assessment of the disease status,
-Consumptions of analgesic medication (including NSAIDs),
-Improvement in the patient's health related quality of life,
To assess safety of the studied products in patients with symptomatic knee OA.

Secondary ID(s)

L00023 GE 409

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 19/12/2018
• Date Completed: 27/07/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-000871-19/results