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

Osteoarthrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291499
• Other study ID #: 03CH/Ct06
• Status: Completed
• Phase: Phase 3
• Start date: June 2005
• Est. completion date: August 2010

Study information

• Verified date: February 2021
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: August 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients of either sex

• Aged 40 and over

• Outpatients

• Patients fulfilling the American Congress of Rheumatology (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 dysplasias

• Intra-articular injection in a hand joint from less than 3 months

• Basic treatment of arthritis with symptom-modifying agents (chondroitin sulfate, glucosamine sulfate, diacerhein, 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthrosis

Intervention

Drug:
• Chondroitin 4&6 sulfate (Condrosulf)
800 mg/day for 6 months

Other:
• Placebo
800 mg placebo/day for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

References & Publications (18)

Altman R, Alarcón 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. — View Citation

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. — View Citation

Bucsi L, Poór 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. — View Citation

Cicuttini FM, Spector TD. Osteoarthritis in the aged. Epidemiological issues and optimal management. Drugs Aging. 1995 May;6(5):409-20. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lequesne M. [Symptomatic slow-action anti-arthritic agents: a new therapeutic concept?]. Rev Rhum Ed Fr. 1994 Feb;61(2):75-9. French. — View Citation

Mazières B, Loyau G, Menkès 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. — View Citation

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. — View Citation

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. — View Citation

Ronca F, Palmieri L, Panicucci P, Ronca G. Anti-inflammatory activity of chondroitin sulfate. Osteoarthritis Cartilage. 1998 May;6 Suppl A:14-21. — View Citation

Uebelhart D, Malaise M, Marcolongo R, de Vathaire 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. Erratum in: Osteoarthritis Cartilage. 2007 Aug;15(8):979. DeVathaire, Florent [corrected to de Vathaire, Florent]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Volpi N. Oral bioavailability of chondroitin sulfate (Condrosulf) and its constituents in healthy male volunteers. Osteoarthritis Cartilage. 2002 Oct;10(10):768-77. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Global Spontaneous Pain Intensity of Target Hand	Intensity of global spontaneous pain is evaluated by the patient himself on a Huskisson's visual analogue scale (VAS) of 100 mm. 0=no pain 100=max pain Change calculated as difference between Month 6 value and baseline value target hand is defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand.	6 months
Primary	Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand	Functional Index for Hand Osteoarthritis (Dreiser's Index). Range 0-30 Patients reported the severity of their symptoms by answering a set of 10 questions. Severity was rated on a numerical scale (0 = possible without difficulty, 1 = possible with slight difficulty, 2 =possible with great difficulty, and 3 = impossible), being 30 points the worst possible pain score.; Change calculated as difference between the month 6 value and baseline value; Target hand defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand	6 month
Secondary	Investigator Global Evaluation on Efficacy	Global impression of the efficacy judged by the Investigators at month 6 by means of a visual analogue scale from 0 (no efficacy) to 100 mm (very good efficacy)	6 months
Secondary	Change in Grip Strength	Grip strength determined on both hands using a Jamar dynamometer.Patients were required to grip the dynamometer handle and squeeze as hard as possible according to their individual pain limits. The right hand grip was measured first, then the left; this procedure was performed 3 times. The mean value of these 3 measurements was recorded.; Change calculated as difference between the month 6 value and baseline value	6 months
Secondary	Change in Morning Stiffness Duration	Change in morning stiffness duration calculated as the difference between the month 6 value and the baseline value	6 months
Secondary	Consumption of Paracetamol	Total consumption (between ^baseline and month 6) of paracetamol (500 mg tablets) reported by the patients on a daily diary	6 months