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

NCT00291499 | Completed Phase 3 Results

• 1 other identifier: 03CH/Ct06
• Study Type: interventional
• Target: 163
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteoarthrosis

Keywords

symptomatic OA of the hand

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Investigator Global Evaluation on Efficacy

  6 months

• Change in Grip Strength

  6 months

• Change in Morning Stiffness Duration

  6 months

• Consumption of Paracetamol

  6 months

Study Arms (2)

Chondroitin 4&6 sulfate (Condrosulf)

ACTIVE COMPARATOR

Drug: Chondroitin 4&6 sulfate (Condrosulf)

placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Chondroitin 4&6 sulfate (Condrosulf) DRUG

800 mg/day for 6 months

Chondroitin 4&6 sulfate (Condrosulf)

Placebo OTHER

800 mg placebo/day for 6 months

placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Related Publications (19)

• Lequesne M. [Symptomatic slow-action anti-arthritic agents: a new therapeutic concept?]. Rev Rhum Ed Fr. 1994 Feb;61(2):75-9. No abstract available. French.

  PMID: 7920505 BACKGROUND

• 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. doi: 10.1002/art.20867.

  PMID: 15751094 BACKGROUND

• 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. doi: 10.1016/j.joca.2004.01.004.

  PMID: 15023378 BACKGROUND

• Cicuttini FM, Spector TD. Osteoarthritis in the aged. Epidemiological issues and optimal management. Drugs Aging. 1995 May;6(5):409-20. doi: 10.2165/00002512-199506050-00007.

  PMID: 7647428 BACKGROUND

• 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.

  PMID: 8210583 BACKGROUND

• Volpi N. Oral bioavailability of chondroitin sulfate (Condrosulf) and its constituents in healthy male volunteers. Osteoarthritis Cartilage. 2002 Oct;10(10):768-77. doi: 10.1053/joca.2002.0824.

  PMID: 12359162 BACKGROUND

• 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.

  PMID: 1772467 BACKGROUND

• 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.

  PMID: 8856618 BACKGROUND

• Ronca F, Palmieri L, Panicucci P, Ronca G. Anti-inflammatory activity of chondroitin sulfate. Osteoarthritis Cartilage. 1998 May;6 Suppl A:14-21. doi: 10.1016/s1063-4584(98)80006-x.

  PMID: 9743814 BACKGROUND

• 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. doi: 10.1016/s1063-4584(98)80005-8.

  PMID: 9743813 BACKGROUND

• 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. doi: 10.1016/s1063-4584(98)80008-3.

  PMID: 9743816 BACKGROUND

• 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.

  PMID: 1485136 BACKGROUND

• 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. doi: 10.1016/s1063-4584(98)80009-5.

  PMID: 9743817 BACKGROUND

• 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. doi: 10.1016/s1063-4584(98)80011-3.

  PMID: 9743819 BACKGROUND

• 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. doi: 10.1016/s1063-4584(98)80010-1.

  PMID: 9743818 BACKGROUND

• 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. doi: 10.1007/s10067-002-8290-7.

  PMID: 12111630 BACKGROUND

• 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.

  PMID: 7583182 BACKGROUND

• 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. doi: 10.1002/art.1780331101.

  PMID: 2242058 BACKGROUND

• 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. doi: 10.1002/art.30574.

  PMID: 21898340 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Project Leader
• Organization: IBSA Institut biochimique

rd@ibsa.ch

0041 58360100

Study Officials

• Cem Gabay, Prof. Dr.

  HUG - Hôpitaux universitaires de Genève

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 14, 2006
• Study Start: June 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: August 1, 2010
• Last Updated: March 4, 2021
• Results First Posted: March 4, 2021

Record last verified: 2021-02