Effect of Structum® (chondroitin sulfate) on cartilage volume in knee osteoarthritis
| ISRCTN | ISRCTN33423639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33423639 |
| Secondary identifying numbers | L00023 GE 403 |
- Submission date
- 28/04/2011
- Registration date
- 17/06/2011
- Last edited
- 21/03/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Jean-Jacques Railhac
Scientific
Scientific
Service Central de Radiologie et dImagerie Médicale
Hôpital Purpan
1 place du Docteur Baylac
Toulouse
31059
France
Study information
| 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 |
| Participant information sheet | Not available in the web format, please use the contact details below to request a patient information sheet |
| 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) |
| 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 40 patients |
| 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 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
31059
France
Sponsor information
Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
Industry
Industry
Address 3
Avenue Hubert Curien
Toulouse
31035
France
| Website | http://www.pierre-fabre.com |
|---|---|
"ROR" |
https://ror.org/04hdhz511 |
Funders
Funder type
Industry
Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2012 | Yes | No |
