Condition category
Musculoskeletal Diseases
Date applied
28/04/2011
Date assigned
17/06/2011
Last edited
21/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jean-Jacques Railhac

ORCID ID

Contact details

Service Central de Radiologie et d’Imagerie Médicale
Hôpital Purpan
1 place du Docteur Baylac
Toulouse
31059
France

Additional identifiers

EudraCT 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

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

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

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

Phase

Not Applicable

Drug names

Structum® (chondroitin sulfate)

Primary outcome measures

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. Patient’s and investigator’s global assessment scores

Overall trial start date

31/08/2004

Overall trial end date

08/06/2006

Reason abandoned

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

Patient

Age group

Senior

Gender

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

Trial participating centre

Service Central de Radiologie et d’Imagerie 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

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22729470

Publication citations

  1. Results

    Railhac JJ, Zaim M, Saurel AS, Vial J, Fournie B, Effect of 12 months treatment with chondroitin sulfate on cartilage volume in knee osteoarthritis patients: a randomized, double-blind, placebo-controlled pilot study using MRI., Clin. Rheumatol., 2012, 31, 9, 1347-1357, doi: 10.1007/s10067-012-2022-4.

Additional files

Editorial Notes