|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
5 January 2021 |
|
Main ID: |
ISRCTN04305346 |
|
Date of registration:
|
12/04/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
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 |
|
Date of first enrolment:
|
15/09/2008 |
|
Target sample size:
|
800 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN04305346 |
|
Study type:
|
Interventional |
|
Study design:
|
Multicentre randomised double-blind double placebo-controlled parallel group study
(Treatment)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Patrice
Fardellone |
|
Address:
|
Service de Rhumatologie
CHU Nord
80054
Amiens
France |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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
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
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Osteoarthritis of the knee
Musculoskeletal Diseases
Other arthrosis
|
|
Intervention(s)
|
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(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(s)
|
1. Responders (OARSI-OMERACT criteria)
2. Patient?s and investigator?s global assessment scores
3. Consumption of analgesics medication (including NSAIDs)
4. Quality of life assessment (SF12 & OAKHQOL)
|
|
Secondary ID(s)
|
|
L00023 GE 409
|
|
Source(s) of Monetary Support
|
|
Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
|
|
Ethics review
|
Status:
Approval date:
Contact:
Committee for the Protection of Persons (CPP) NORTHWEST II (Comité de Protection des Personnes (CPP) NORD-OUEST II), approved on 28 March 2008
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
17/06/2009 |
|
URL:
|
|
|
|