Condrosulf vs Celebrex vs Placebo in the Treatment of Knee OA

Knee Osteoarthritis Clinical Trial

Official title:

A Multicentre, Comparative, Randomised, Double-blind, Double-dummy Clinical Trial on the Efficacy and Safety of Condrosulf Versus Celebrex and Versus a Placebo in the Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079727
• Other study ID #: 12EU/Ct06
• Secondary ID: 2013-001619-62
• Status: Completed
• Phase: Phase 3
• First received: February 28, 2014
• Last updated: March 1, 2017
• Start date: June 12, 2014
• Est. completion date: June 16, 2016

Study information

• Verified date: March 2017
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: June 16, 2016
• Est. primary completion date: October 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• chondroitin sulfate

• celecoxib

• placebo

Locations

Country	Name	City	State
Belgium	Unité d'exploration du metabolism osseux, CHU, Polyclinique universitaires L-Brull	Liege
Czech Republic	Interni a revmatologicka ordinace	Breclav
Czech Republic	Ortopedicka Ambulance	Brno
Czech Republic	Vesalion s.r.o.	Ostrava
Czech Republic	Thomayerova nemocnice - Revmatologicke a rehabilitacne oddeleni	Praha - Krc
Czech Republic	Revmatologicky ustav	Praha 2
Czech Republic	Medical Plus	Uherske Hradiste
Italy	Azienda Osp. Univ. Di Careggi	Firenze
Poland	Klinika Zdrowej Kosci	Lodz
Poland	Lubelskie Centrum Diagnostyczne	Swidnik
Poland	SOLB	ul. Jana III Sobieskiego
Poland	Medica Pro Familia	Warszawa
Poland	Zdrowie Osteo-Medic	Wiejska
Switzerland	Bethesda-Spital	Basel
Switzerland	HFR Fribourg - Hôpital Cantonal	Fribourg
Switzerland	Universitätsspital Zürich, Rheumaklinik	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Italy,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment compliance		Day 1, 30, 91 and 182
Primary	Lequesne's Index	Decrease in the scores of the Lequesne's Index from Day 1 to Day 182.	Day 1 and Day 182
Primary	Pain (VAS in mm)	Decrease in the VAS (pain in mm) from Day 1 to Day 182	Day 1 and Day 182
Secondary	Lequesne's Index	Evolution from Day 1 to Day 30, Day 90 and Day 182	Day 1, 30, 90 and 182
Secondary	Pain (VAS in mm)	Evolution of the pain on VAS (in mm) from Day 1 to Day 30, Day 91 and Day 182	Day 1, 30, 91 and 182
Secondary	MCII (minimal clinically important improvement)		Day 1, 30, 91 and 182
Secondary	PASS (patient acceptable symptom state)		Day 1, 30, 91 and 182
Secondary	Consumption of Paracetamol		Day 1, 30, 91 and 182
Secondary	Global efficacy assessment	Global efficacy assessed by the patient and the Investigator by means of a semi-quantitative verbal scale.	At Day 30, 91 and 182
Secondary	Number of adverse events related to the treatments		At Day 30, 91 and 182
Secondary	Number of drop-outs due to AE (adverse event) related to the treatment		At Day 30, 91 and 182