Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
L00023 GE 403
Study information
Scientific title
Effect of 12 months treatment with Structum® (chondroitin sulfate) on cartilage volume in knee osteoarthritis patients: a randomised, double-blind, placebo-controlled pilot study using magnetic resonance imaging (MRI)
Acronym
Study hypothesis
There is a correlation between clinical symptoms and decrease of cartilage volume in patients suffering from knee osteoarthritis (KOA).
Ethics approval(s)
Advisory Committee for the Protection of Persons in Biomedical Research [Comité Consultatif pour la Protection des Personnes dans la Recherche Biomédicale (Ethics Committee)] of Toulouse 1 approved on 19th May 2004
Study design
Multicentre randomised double-blind placebo-controlled parallel group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in the web format, please use the contact details below to request a patient information sheet
Condition
Knee osteoarthritis
Intervention
1. Group Structum® : 1 capsule (500mg chondroitin sulfate) two times a day (b.i.d) for 12 months.
2. Group Placebo : 1 capsule Placebo two times a day (b.i.d)
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Structum® (chondroitin sulfate)
Primary outcome measure
The correlation between the evolution of clinical symptoms (Lequesne Index and VAS pain) and the total volume of cartilage after 12 months treatment
Secondary outcome measures
1. Mean evolution from baseline of the total volume of cartilage and of each knee compartment
2. Evolution of other morphological osteo-articular lesions (sub-chondral oedema, meniscal lesions, synovitis)
3. Mean variation of the pain score (VAS) and of the Lequesne Index
4. Patients and investigators global assessment scores
Overall study start date
31/08/2004
Overall study end date
08/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged from 50 to 75 years
2. Symptomatic femorotibial KOA fulfilling American College of Rheumatology (ACR) criteria for KOA
3. A Kellgren-Lawrence radiological grade II or III
4. A global pain score greater than or equal to 30 on a 100mm Visual Analogue Scale (VAS)
Participant type(s)
Patient
Age group
Senior
Sex
Both
Target number of participants
40 patients
Participant exclusion criteria
1. Isolated symptomatic femoropatellar osteoarthritis of the knee
2. Inflammatory, infectious or metabolic arthritis
3. Contraindication to MRI examination
4. Intra-articular steroid injection or hyaluronic acid injections in the 3 months preceding inclusion
5. Non steroidal anti-inflammatory drugs (NSAIDs) in the 2 days preceding inclusion
Recruitment start date
31/08/2004
Recruitment end date
08/06/2006
Locations
Countries of recruitment
France
Study participating centre
Service Central de Radiologie et dImagerie Médicale
Toulouse
31059
France
Sponsor information
Organisation
Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
Sponsor details
Address 3
Avenue Hubert Curien
Toulouse
31035
France
Sponsor type
Industry
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2012 | Yes | No |