A study to evaluate the efficacy and safety of Condrosulf® versus Celebrex® and versus a placebo in the treatment of knee osteoarthritis

• Conditions: knee osteoarthritisi, the most common form of arthritis and a leading cause of morbidity and disability; MedDRA version: 17.0Level: PTClassification code 10031161Term: OsteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-001619-62-BE
• Lead Sponsor: IBSA, Institut Biochimique S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-16
• Last Update Posted: 1 February 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Outpatients of either sex, aged = 50 years
Patients affected by primary knee osteoarthritis of the medial or lateral femoro-tibial compartment
Diagnosis according to the American College of Rheumatology (ACR) criteria
Knee osteoarthritis evolving for more than 6 months
Patients suffering from regular pain and functional disorders from at least 3 months
Accomplishing a score = 7 of Lequesne index for the knee osteoarthritis
Assessing pain on Huskisson’s VAS = 50mm
With radiography dated less than six months showing a remaining articular joint space
Without such an axial disorder to justify an osteotomy
Women taking contraceptive measures if not in menopause
Patients able to understand and follow the study protocol
Patients who have signed the written informed consent for their participation in the clinical trial

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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

With a history of heart attack, ischemic heart disease or cerebrovascular disease (including transient ischemic attack
Having or have had peripheral arterial disease or past surgery of peripheral arteries
With a history or currently significant coagulation defect or/and blood dyscrasia
With high risk of CV events
With any acute or chronic infections requiring antimicrobial therapy or serious viral (e.g. hepatitis, HIV positivity) or fungal infections
With a history of recurrent or currently GI ulceration or active inflammatory bowel diseases (e.g. Crohn’s disease or ulcerative colitis)
Having been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication
Having severe liver or kidney disease
With allergy to Celebrex® or any of the other ingredients of Celebrex®
Having had an allergic reaction to sulphonamides
Having had, as a result of intake of acetylsalicylic acid or other NSAIDs, asthma, nose polyps, severe nose congestion, or an allergic reaction such as itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing
Presenting lactose intolerance

Mild or not symptomatic knee osteoarthritis : < 7 of Lequesne index,
or pain on Huskisson’s VAS (Visual Analogic Scale) < 50mm
Predominantly femoro-patellar osteoarthritis
Destructive osteoarthritis of the knee justifying a surgery in the following 6 months
Osteoarthritis with hydarthrosis requiring a puncture or an infiltration
Important genu varum or valgum > 8° (physiological angle including)
Knee joint surgery in the last 3 months (e.g. chondroscopy, arthroscopy)
Viscosupplementation, tidal lavage in the last 6 months
Arthritis and metabolic arthropathies, Paget’s illness
Having consumed:
basic treatment of arthritis with SYSADOA (chondroitin sulphates, glucosamine sulphates, diacerrhein, hyaluronic acid) in the last 3 months
treatment with corticoids, by any administration route during the last month
any medication having an influence on pain:
NSAIDs in the 5 days preceding the inclusion (wash out period considering 5 half-lives of the drug)
hypnotics, muscle relaxants, anxiolytics, if the intake has started less than 8 days before inclusion
paracetamol in the 10 hours preceding the inclusion
Foreseen physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) in the next six months (study period)
Presenting:
serious organic diseases as renal or hepatic insufficiency or blood dyscrasia
psychiatric illness hindering the protocol compliance, alcoholism, ongoing or < 1 year drug dependency

Pregnant or likely to become it during clinical trial or lactating
Having participated in other clinical trials in the month preceding the clinical trial

Study & Design

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