NCT00291499

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Osteoarthrosis

Interventions

Type	Name	Description
DRUG	Chondroitin 4&6 sulfate (Condrosulf)	800 mg/day for 6 months
OTHER	Placebo	800 mg placebo/day for 6 months

Timeline

• Start date: 2005-06-01
• Primary completion: 2009-12-01
• Completion: 2010-08-01
• First posted: 2006-02-14
• Last updated: 2021-03-04
• Results posted: 2021-03-04