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

Clinical Evaluation of Condrosulf 800 mg in the Treatment of Symptomatic OA of the Hand: a 6-month, Double-blind, Placebo Controlled Study

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.

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

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