Condrosulf 800 Otzivi
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.
ACS4-ACS6, ADAMTS7B, aggrecan, agrin, biglycan, biostat, CDS, chondroitin sulfate A, chondroitin sulfate C, chondroitin sulfate proteoglycan, chondroitin sulfates. Condrosulf® is a slow acting cartilage structure modifying agent. Condrosulf is a medical grade chondroitin sulfate manufactured by IBSA Biochimique, Lugano Switzerland. Condrosulf® has been demonstrated in clinical trials to significantly slow the erosion of cartilage and improve mobility in joints affected by osteoarthritis.
Condition or disease Intervention/treatment Phase Osteoarthrosis Drug: Chondroitin 4&6 sulfate (Condrosulf) Other: Placebo Phase 3. 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.
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Layout table for study information Study Type: Interventional (Clinical Trial) Actual Enrollment: 162 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, 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 Study Start Date: June 2005 Actual Primary Completion Date: December 2009 Actual Study Completion Date: August 2010. 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 ( or = 40 mm at inclusion time). • Showing a FIHOA score > Agitator design software download. 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).