Condrosulf vs Celebrex vs Placebo in the Treatment of Knee OA

NCT ID: NCT02079727

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 604 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-12
• Study Completion Date: 2016-06-16

Brief Summary

The purpose of this study is to confirm the efficacy and safety of 800 mg Chondroitin 4&6 sulfate (Condrosulf) vs placebo once a day for 6 months in the symptomatic treatment of knee osteoarthritis. A third group, Celecoxib 200 mg (Celebrex) once a day, will be used as active comparator.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Condrosulf (Chondroitin 4&6 sulfate)

1 tablet of Condrosulf 800 mg and 1 capsule of placebo of Celebrex once a day for 182 days

Group Type: EXPERIMENTAL

chondroitin sulfate

Intervention Type: DRUG

Placebo (PBO) 800 mg tablet and Placebo (PBO) 200 mg capsule

1 tablet of PBO of Condrosulf and 1 capsule of PBO of Celebrex, once a day for 182 days

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Celebrex 200 mg capsule

1 capsule of 200 mg of Celebrex and 1 tablet of 800 mg placebo of Condrosulf once a day for 182 days

Group Type: ACTIVE_COMPARATOR

celecoxib

Intervention Type: DRUG

Interventions

chondroitin sulfate

Intervention Type: DRUG

celecoxib

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

Condrosulf; Celebrex; placebo for chondroitin sulfate and placebo for celecoxib

Eligibility Criteria

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
• Kellgren & Lawrence grade I-III
• 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's index for the knee osteoarthritis
• Assessing pain on Huskisson's VAS ≥ 50 mm
• 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
• Women having negative pregnancy test
• Patients able to understand and follow the study protocol
• Patients who have signed the written informed consent for their participation in the clinical trial

Exclusion Criteria

• With a history of heart attack, ischemic heart disease or cerebrovascular disease (including transient ischemic attacks)
• Having or have had peripheral arterial disease or past surgery orf peripheral arteries
• With a history or currently significat coagulation defect or/and blood dyscrasia
• With high risk of cardiovascular 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 gastrointestinal 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's index,
• Pain on Huskisson's VAS (Visual Analogic Scale) < 50 mm
• Predominantly femoro-patellar osteoarthritis
• Destructive osteoarthritis of the knee justifying a surgery in the following 6 months
• Osteoarthritis with hydrarthrosis requiring a puncture or an infiltration
• Important genu varum or valgus >8° (physiological angle including)
• Kellgren & Lawrence grade IV
• 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, symptomatic slow acting drugs for osteoarthrithis (chondroitin sulphates, glucosamine sulphates, diacerhein, hyaluronic acid and food supplement for joint care) in the last 3 months; treatment with corticoids, by any administration route during the last month; any medication having an influence on pain:
• NSAIDs (nonsteroidal anti-inflammatory drugs) 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 psychiatric illness hindering the protocol complaince, alcoholism, ongoing or < 1 year drug dependency
• Pregnant or likely to become it during clinical trial or lactating
• Women having positive pregnancy test
• Having participated in other clinical trials in the month preceding the clinical trial.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IBSA Institut Biochimique SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Yves Reginster, Prof. MD PhD

Role: PRINCIPAL_INVESTIGATOR

Unité d'Exploration du Métabolisme Osseux, CHU Centre ville, Polycliniques Universitaires L-Brull, Liège, Belgium

Locations

Unité d'exploration du metabolism osseux, CHU, Polyclinique universitaires L-Brull

Liège, Liege, Belgium

Ortopedicka Ambulance

Brno, , Czechia

Interni a revmatologicka ordinace

Břeclav, , Czechia

Vesalion s.r.o.

Ostrava, , Czechia

Revmatologicky ustav

Prague, , Czechia

Thomayerova nemocnice - Revmatologicke a rehabilitacne oddeleni

Praha - Krc, , Czechia

Medical Plus

Uherské Hradiště, , Czechia

Azienda Osp. Univ. Di Careggi

Florence, , Italy

Klinika Zdrowej Kosci

Lodz, , Poland

Lubelskie Centrum Diagnostyczne

Świdnik, , Poland

SOLB

Ul. Jana III Sobieskiego, , Poland

Medica Pro Familia

Warsaw, , Poland

Zdrowie Osteo-Medic

Wiejska, , Poland

Bethesda-Spital

Basel, , Switzerland

HFR Fribourg - Hôpital Cantonal

Fribourg, , Switzerland

Universitätsspital Zürich, Rheumaklinik

Zurich, , Switzerland

Countries

Belgium; Czechia; Italy; Poland; Switzerland

Other Identifiers

2013-001619-62

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12EU/Ct06

Identifier Type: -

Identifier Source: org_study_id