AN INTERNATIONAL, MULTICENTRE, DOUBLE-BLIND, RANDOMISED STUDY OF THE EFFECT OF DIACEREIN VS CELECOXIB ON SYMPTOMS AND STRUCTURAL CHANGES IN SYMPTOMATIC KNEE OSTEOARTHRITIS PATIENTS AS ASSESSED BY MAGNETIC RESONANCE IMAGING

Phase 1

• Conditions: Pain reduction in symptomatic knee osteoarthritis (OA); MedDRA version: 20.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000018839; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-002933-23-CZ
• Lead Sponsor: TRB CHEMEDICA INTERNATIONAL SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-02
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Men and women of at least 50 years of age;
2. Patients followed in an ambulatory clinic;
3. Patients presenting primary OA of the knee according to ACR criteria;
4. Patients with OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
5. Patients with a minimum joint space width =2 mm in the medial tibio-femoral compartment on standing knee X-ray (MRI structural study only);
6. Patients with knee pain on most days of the month before entering into the study;
7. Patients with a VAS pain score (0-100 mm) while walking on a flat surface = 40 mm (Visit 1 (Screening)and Visit 2 (Inclusion Visits));
8. Patients with no clinically significant laboratory abnormalities in the judgment of the investigator;
9. Female patients who are postmenopausal with confirmed amenorrhea for at least one year before entering this study and those who underwent tubal ligation, oophorectomy or hysterectomy must agree to an hormonal (FSH) dosage at Screening visit ;
10. Patients agreeing to sign the Informed Consent Form prior to any study-related activities after having been clearly informed of its methods and constraints;
11. Patients not taking part in another clinical study;
12. Patients agreeing to respect the protocol by attending the visits related to the study.
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 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

Criteria Related to Individual Characteristics of the Patient
1. Patients with secondary knee OA
2. Patients with known hypersensitivity to Diacerein or to anthraquinone-containing product, hypersensitivity to Celecoxib, who have demonstrated allergic-type reactions to sulphonamides, experienced asthma, urticaria or allergic-type reactions after taking sulphonamides, aspirin (acetyl salicylic acid [ASA]), lactose, NSAIDs, acetaminophen
or paracetamol;
3. Patients with a known history of diarrhoea, more particularly if 65 years of age and older.
4. Patients with active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma;
5. Patients with other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget’s disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson’s disease, osteochondromatosis, seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease;
6. Pain in other parts of the body greater than the knee pain that could interfere with the evaluation of the index joint;
7. Patients with fibromyalgia;
8. Patients with isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only;
9. Patients with Class IV functional capacity using the American Rheumatism Association criteria;
10. Patients who have had surgery in any lower limb or arthroscopy, aspiration or lavage in any lower limb joint within 180 days of the Inclusion Visit (Visit 2);
11. Patients who have had meniscal surgery on the study knee;
12. Patients who have undergone total knee replacement in the contralateral knee within 182 days prior to the Screening Visit (Visit 1).
13. Patients with co-morbid conditions or joint deformity that restrict knee function;
14. Patients with a history ofheart attack or stroke, or who have had serious diseases of the heart such as congestive heart failure (functional classes II-IV of the NYHA);
15. Patients who have significant risk factors for heart attack or stroke will be assessed carefully. Risk factors for heart attack and stroke include high blood pressure (treated or untreated), high cholesterol,
diabetes and smoking. The global risk assessment will be assessed using the American Heart Association (AHA) assessment of CV risk tables. Patients with high risk of CV events will be excluded;
[continues to 31 criteria]
32. Patients using corticosteroids (oral, injectable; exception of intraarticular/soft tissueinjection at the exclusion of the target knee), indomethacin, therapeutic dose of glucosamine, chondroitin sulfate or Diacerein or ASU during the 12 weeks preceding inclusion (intraarticular injections of corticosteroids in the contralateral knee is allowed during the study);
33. Patients using hyaluronic acid (intra-articular target knee) during the 26 weeks preceding inclusion;
34. Patients using natural health products (e.g. capsaicin, boswellia, willow bark), and creams and analgesic gels (e.g. camphor and alcohol based gels) during one week preceding inclusion;
35. Patients using natural health products susceptible to increase the risk of bleeding (e.g. garlic, dong quai, etc.) during one week preceding inclusion;
36. Patients receiving radioactive synovectomy (target knee) during the 12 weeks preceding inclusion;
37. Patien

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified