Efficacy and safety of two Chondroitin Sulfate preparations in patients with symptomatic osteoarthritis of the knee
| ISRCTN | ISRCTN04305346 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04305346 |
| Secondary identifying numbers | L00023 GE 409 |
- Submission date
- 07/03/2011
- Registration date
- 12/04/2011
- Last edited
- 18/12/2020
- 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 of protocol
Not provided at time of registration
Contact information
Prof Patrice Fardellone
Scientific
Scientific
Service de Rhumatologie
CHU Nord
Amiens
80054
France
Study information
| Study design | Multicentre randomised double-blind double 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 | 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 |
| Study acronym | Structum® vs Chondrosulf® study |
| Study objectives | 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(s) | Committee for the Protection of Persons (CPP) NORTHWEST II (Comité de Protection des Personnes (CPP) NORD-OUEST II), approved on 28 March 2008 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Structum®, Chondrosulf® |
| Primary outcome measure | 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 study start date | 15/09/2008 |
| Completion date | 17/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned: 800 patients |
| Total final enrolment | 837 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/09/2008 |
| Date of final enrolment | 17/06/2009 |
Locations
Countries of recruitment
- France
Study participating centre
Service de Rhumatologie
Amiens
80054
France
80054
France
Sponsor information
Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
Industry
Industry
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 | 01/06/2013 | 18/12/2020 | Yes | No |
Editorial Notes
18/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
