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Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand

This study is currently recruiting participants.
Verified by IBSA Institut Biochimique SA, September 2006

Sponsored by: IBSA Institut Biochimique SA
Information provided by: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT00291499
  Purpose

The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis.

Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.


Condition Intervention Phase
Osteoarthrosis
Drug: Chondroitin 4&6 sulfate (Condrosulf)
Phase IV

MedlinePlus related topics:   Osteoarthritis   

Drug Information available for:   Chondroitin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Clinical Evaluation of Condrosulf 800 Mg in the Treatment of Symptomatic OA of the Hand: a 6-Month, Double-Blind, Placebo Controlled Study

Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • Intensity of global spontaneous pain for both hands is evaluated by the patient himself on a Huskisson's visual analogue scale (VAS) of 100 mm and the score of Dreiser's algo-functional index (FIHOA).

Secondary Outcome Measures:
  • Global impression of efficacy.
  • Grip strength measured manometrically.
  • Morning stiffness duration
  • Consupmtion of paracetamol
  • Tolerability
  • Adverse events
  • Treatment compliance
  • Biological markers of arthritis

Estimated Enrollment:   160
Study Start Date:   June 2005
Estimated Study Completion Date:   December 2007

Detailed Description:

The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis in 160 randomised patients.

Primary endpoints:

Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.

Secondary endpoints are:

Efficacy evaluation: Global impression of efficacy expressed by the patient and the physician (VAS), Grip strength (measured manometrically); Morning stiffness duration; Consumption of Paracetamol; Tolerability (4-point verbal scale); Adverse Events occurring during the treatment period; Other parameters:Treatment compliance; Biological markers of arthritis

  Eligibility
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients of either sex
  • Aged 40 and over
  • Outpatients
  • Patients fulfilling the ACR criteria for the reporting of hand OA
  • Patients showing X-ray features of hand OA on at least two joints (2 IP and/or 1 IP and 1 TMC) of the dominant hand on standard plain radiographs (< 6 month).
  • Suffering from regular spontaneous pain on the dominant hand (VAS > or = 40 mm at inclusion time).
  • Showing a FIHOA score > or = 6.
  • Having had at least two painful flares in a finger joint during the previous 12 month.
  • Patients who have signed the written informed consent for their participation in the study
  • Patients able to understand and follow the protocol.
  • Patients with a satisfying health and nutritional status.
  • Female subjects of childbearing potential using, within three months prior to the inclusion in the study, a reliable form of contraception during the course of the study (oral contraceptive pill, intrauterine device or condoms) or female of non childbearing potential (hysterectomy, bilateral ovariectomy or tubal section/ligation).
  • Female subjects of childbearing potential with a negative urinary pregnancy test before the inclusion in the study.

Exclusion Criteria:

  • Inflammatory joint disease of other origin
  • Septic arthritis
  • Chronic inflammatory joint disease
  • Previous articular fracture of the concerned articulations
  • Use of analgesic therapy for other indications
  • Receiving oral corticosteroids
  • Mono-articular posttraumatic OA of the finger
  • Planning surgery of the hands in the following 6 months
  • Patients suffering or having suffered from secondary osteoarthritis after one of the following diseases:

    • Infectious arthritis - Acromegaly
    • Ochronosis - Hemachromatosis
    • Gout - Wilson’s disease
    • Chondrocalcinosis - Paget’s disease
    • Osteochondrosis - Mutation of collagen
    • Genetic problems (for ex. hypermobility) - Previous joint fracture
    • Arthropathies of different aetiologies - Algodystrophy (M. Sudeck)
  • Congenital abnormalities
  • Recurrent pseudogout
  • Major displasias
  • Intra-articular injection in a hand joint from less than 3 months
  • Basic treatment of arthritis with symptom-modifying agents (chondroitin sulfate, glucosamine sulfate, diacerrhein, hyaluronic acid) in the last 3 months
  • Articular lavage in the last 3 months
  • Treatment with corticoids, by any administration route during the last month
  • Patient suffering from frequent asthma crises
  • Physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) on the hands foreseeable in the next year
  • Serious organic diseases: heart failure, renal or hepatic insufficiency, blood dyscrasia, serious infection
  • Participation in other clinical trials in the two months preceding the study
  • Known or ascertained hypersensitivity to the active ingredient of the tested drug.
  • Patients refusing to sign the written informed consent form
  • Patients who do not co-operate, not respecting the protocol requirements
  • Pregnant or lactating women
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291499

Contacts
Contact: Cem Gabay, Prof. Dr.     +41 22 3823501 ext +41 22     cem.gabay@hcuge.ch    
Contact: Carole Medinger, Dr.     +41 22 3823500 ext +41 22     carole.medinger@hcuge.ch    

Locations
Switzerland
HUG Hôpitaux Universitaires de Genève     Recruiting
      Genève, Switzerland, 1211
      Contact: Cem Gabay, Prof. Dr.     +41 22 382 3501 ext +4122     cem.gabay@hcuge.ch    
      Contact: Carole Medinger, Dr.     +4122 3823500 ext +4122     carole.medinger@hcuge.ch    
      Principal Investigator: Cem Gabay, Prof. Dr.            

Sponsors and Collaborators
IBSA Institut Biochimique SA

Investigators
Principal Investigator:     Cem Gabay, Prof. Dr.     HUG Hôpitaux Universitaires de Genève    
  More Information


Publications:
Lequesne M. [Symptomatic slow-action anti-arthritic agents: a new therapeutic concept?] Rev Rhum Ed Fr. 1994 Feb;61(2):75-9. French. No abstract available.
 
Michel BA, Stucki G, Frey D, De Vathaire F, Vignon E, Bruehlmann P, Uebelhart D. Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: a randomized, controlled trial. Arthritis Rheum. 2005 Mar;52(3):779-86.
 
Uebelhart D, Malaise M, Marcolongo R, DeVathaire F, Piperno M, Mailleux E, Fioravanti A, Matoso L, Vignon E. Intermittent treatment of knee osteoarthritis with oral chondroitin sulfate: a one-year, randomized, double-blind, multicenter study versus placebo. Osteoarthritis Cartilage. 2004 Apr;12(4):269-76.
 
Cicuttini FM, Spector TD. Osteoarthritis in the aged. Epidemiological issues and optimal management. Drugs Aging. 1995 May;6(5):409-20. Review.
 
Howell DS, Altman RD. Cartilage repair and conservation in osteoarthritis. A brief review of some experimental approaches to chondroprotection. Rheum Dis Clin North Am. 1993 Aug;19(3):713-24. Review.
 
Volpi N. Oral bioavailability of chondroitin sulfate (Condrosulf) and its constituents in healthy male volunteers. Osteoarthritis Cartilage. 2002 Oct;10(10):768-77.
 
Conte A, de Bernardi M, Palmieri L, Lualdi P, Mautone G, Ronca G. Metabolic fate of exogenous chondroitin sulfate in man. Arzneimittelforschung. 1991 Jul;41(7):768-72.
 
Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L. Comparison of the antiinflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. J Rheumatol. 1996 Aug;23(8):1385-91.
 
Ronca F, Palmieri L, Panicucci P, Ronca G. Anti-inflammatory activity of chondroitin sulfate. Osteoarthritis Cartilage. 1998 May;6 Suppl A:14-21.
 
Uebelhart D, Thonar EJ, Zhang J, Williams JM. Protective effect of exogenous chondroitin 4,6-sulfate in the acute degradation of articular cartilage in the rabbit. Osteoarthritis Cartilage. 1998 May;6 Suppl A:6-13.
 
Bourgeois P, Chales G, Dehais J, Delcambre B, Kuntz JL, Rozenberg S. Efficacy and tolerability of chondroitin sulfate 1200 mg/day vs chondroitin sulfate 3 x 400 mg/day vs placebo. Osteoarthritis Cartilage. 1998 May;6 Suppl A:25-30.
 
Mazieres B, Loyau G, Menkes CJ, Valat JP, Dreiser RL, Charlot J, Masounabe-Puyanne A. [Chondroitin sulfate in the treatment of gonarthrosis and coxarthrosis. 5-months result of a multicenter double-blind controlled prospective study using placebo] Rev Rhum Mal Osteoartic. 1992 Jul-Sep;59(7-8):466-72. French.
 
Bucsi L, Poor G. Efficacy and tolerability of oral chondroitin sulfate as a symptomatic slow-acting drug for osteoarthritis (SYSADOA) in the treatment of knee osteoarthritis. Osteoarthritis Cartilage. 1998 May;6 Suppl A:31-6.
 
Uebelhart D, Thonar EJ, Delmas PD, Chantraine A, Vignon E. Effects of oral chondroitin sulfate on the progression of knee osteoarthritis: a pilot study. Osteoarthritis Cartilage. 1998 May;6 Suppl A:39-46.
 
Verbruggen G, Goemaere S, Veys EM. Chondroitin sulfate: S/DMOAD (structure/disease modifying anti-osteoarthritis drug) in the treatment of finger joint OA. Osteoarthritis Cartilage. 1998 May;6 Suppl A:37-8.
 
Verbruggen G, Goemaere S, Veys EM. Systems to assess the progression of finger joint osteoarthritis and the effects of disease modifying osteoarthritis drugs. Clin Rheumatol. 2002 Jun;21(3):231-43.
 
Dreiser RL, Maheu E, Guillou GB, Caspard H, Grouin JM. Validation of an algofunctional index for osteoarthritis of the hand. Rev Rhum Engl Ed. 1995 Jun;62(6 Suppl 1):43S-53S.
 
Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Gray R, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hand. Arthritis Rheum. 1990 Nov;33(11):1601-10.
 

Study ID Numbers:   03CH/Ct06
First Received:   February 13, 2006
Last Updated:   September 19, 2006
ClinicalTrials.gov Identifier:   NCT00291499
Health Authority:   Switzerland: Swissmedic

Keywords provided by IBSA Institut Biochimique SA:
symptomatic OA of the hand  

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoarthritis
Arthritis
Joint Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 31, 2008




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