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

Launched by IBSA INSTITUT BIOCHIMIQUE SA · Feb 13, 2006

Keywords

ClinConnect 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 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...

Gender

ALL

Eligibility criteria

• 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