Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand - Full Text View

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) Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Sulfate ion

U.S. FDA Resources

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). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global impression of efficacy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Grip strength measured manometrically. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Morning stiffness duration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Consupmtion of paracetamol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Treatment compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Biological markers of arthritis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	162
Study Start Date:	June 2005
Study Completion Date:	August 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Chondroitin 4&6 sulfate (Condrosulf)	Drug: Chondroitin 4&6 sulfate (Condrosulf) 800 mg/day for 6 months
Placebo Comparator: placebo	Other: Placebo 800 mg placebo/day for 6 months

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

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gabay C, Medinger-Sadowski C, Gascon D, Kolo F, Finckh A. Symptomatic effects of chondroitin 4 and chondroitin 6 sulfate on hand osteoarthritis: a randomized, double-blind, placebo-controlled clinical trial at a single center. Arthritis Rheum. 2011 Nov;63(11):3383-91.

Responsible Party:	IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:	NCT00291499 History of Changes
Other Study ID Numbers:	03CH/Ct06
Study First Received:	February 13, 2006
Last Updated:	November 27, 2012
Health Authority:	Switzerland: Swissmedic

Keywords provided by IBSA Institut Biochimique SA:

symptomatic OA of the hand

Additional relevant MeSH terms:

Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013