Plain English Summary
Not provided at time of registration
Trial website
http://www.pfclintrial.com/public/clinical-trials/html/en/trials_register/index.php
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
L00023 GE 409
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in the web format, please use the contact details below to request a patient information sheet
Condition
Osteoarthritis of the knee
Intervention
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
Intervention type
Drug
Phase
Not Applicable
Drug names
Structum®, Chondrosulf®
Primary outcome measures
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 measures
1. Responders (OARSI-OMERACT criteria)
2. Patients and investigators global assessment scores
3. Consumption of analgesics medication (including NSAIDs)
4. Quality of life assessment (SF12 & OAKHQOL)
Overall trial start date
15/09/2008
Overall trial end date
17/06/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned: 800 patients
Participant 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
Recruitment start date
15/09/2008
Recruitment end date
17/06/2009
Locations
Countries of recruitment
France
Trial participating centre
Service de Rhumatologie
Amiens
80054
France
Sponsor information
Organisation
Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
Sponsor details
3
Avenue Hubert Curien
Toulouse
31035
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary