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Efficacy and safety of two Chondroitin Sulfate preparations in patients with symptomatic osteoarthritis of the knee
ISRCTN ISRCTN04305346
DOI 10.1186/ISRCTN04305346
ClinicalTrials.gov identifier
EudraCT number
Public title Efficacy and safety of two Chondroitin Sulfate preparations in patients with symptomatic osteoarthritis of the knee
Scientific title Comparative study of efficacy and safety of Structum® and Chondrosulf® in patients with symptomatic osteoarthritis of the knee: a multicentre, randomised, double-blind, double placebo-controlled, parallel group study
Acronym Structum® vs Chondrosulf® study
Serial number at source L00023 GE 409
Study hypothesis Structum® is non-inferior to Chondrosulf® on pain relief and functional improvement in patients with symptomatic knee osteoarthritis (OA) after 6 month of treatment.
Lay summary
Ethics approval Committee for the Protection of Persons (CPP) NORTHWEST II (Comité de Protection des Personnes (CPP) NORD-OUEST II), approved on 28 March 2008
Study design Multicentre randomised double-blind double placebo-controlled parallel group study
Countries of recruitment France
Disease/condition/study domain Osteoarthritis of the knee
Participants - inclusion criteria Patients aged from 50 to 80 years with symptomatic femorotibial knee OA fulfilling American College of Rheumatology (ACR) criteria for knee OA, with a Kellgren-Lawrence radiological grade II or III, a global pain score greater than or equal to 40 on a 100mm Visual Analogue Scale (VAS) and a Lequesne Index greater than or equal to 7
Participants - exclusion criteria 1. Isolated symptomatic femoropatellar osteoarthritis of the knee
2. Symptomatic hip OA homolateral to the target knee
3. Inflammatory, infectious or metabolic arthritis
4. Bisphosphonates or strontium ranelate in the 3 months preceding inclusion
5. Corticosteroid treatment during the month preceding inclusion
6. Intra-articular steroid injection in the 2 months preceding inclusion
7. Intra-articular hyaluronic acid in the 6 months preceding inclusion
8. Non steroidal anti-inflammatory drugs (NSAIDs) in the 2 days preceding inclusion
9. Articular lavage of target knee in the 3 months preceding inclusion
Anticipated start date 15/09/2008
Anticipated end date 17/06/2009
Status of trial Completed
Patient information material Not available in the web format, please use the contact details below to request a patient information sheet
Target number of participants Planned: 800 patients
Interventions Group Chondrosulf® 1 capsule (400mg Chondroitin) three times a day (t.i.d), i.e.1200mg/day

Group Structum®, : 1 capsule (500mg Chondroitin) two times a day (b.i.d), i.e.1000mg/day
Primary outcome measure(s) Two co-primary efficacy endpoints :
1. Mean variation of the global pain score (VAS) over 24 weeks
2. Mean variation of Lequesne Index over 24 weeks
Secondary outcome measure(s) 1. Responders (OARSI-OMERACT criteria)
2. Patientís and investigatorís global assessment scores
3. Consumption of analgesics medication (including NSAIDs)
4. Quality of life assessment (SF12 & OAKHQOL)
Sources of funding Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
Trial website http://www.pfclintrial.com/public/clinical-trials/html/en/trials_register/index.php
Publications
Contact name Prof  Patrice  Fardellone
  Address Service de Rhumatologie
CHU Nord
  City/town Amiens
  Zip/Postcode 80054
  Country France
Sponsor Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
  Address 3, Avenue Hubert Curien
  City/town Toulouse
  Zip/Postcode 31035
  Country France
  Sponsor website: http://www.pierre-fabre.com
Date applied 07/03/2011
Last edited 12/04/2011
Date ISRCTN assigned 12/04/2011
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