Condition category
Musculoskeletal Diseases
Date applied
07/03/2011
Date assigned
12/04/2011
Last edited
12/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pfclintrial.com/public/clinical-trials/html/en/trials_register/index.php

Contact information

Type

Scientific

Primary contact

Prof Patrice Fardellone

ORCID ID

Contact details

Service de Rhumatologie
CHU Nord
Amiens
80054
France

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. Patient’s and investigator’s 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

http://www.pierre-fabre.com

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

Publication citations

Additional files

Editorial Notes