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Sponsored by: |
IBSA Institut Biochimique SA |
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Information provided by: | IBSA Institut Biochimique SA |
ClinicalTrials.gov Identifier: | NCT00291499 |
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.
Condition | Intervention | Phase |
---|---|---|
Osteoarthrosis |
Drug: Chondroitin 4&6 sulfate (Condrosulf) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 160 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | December 2007 |
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
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients suffering or having suffered from secondary osteoarthritis after one of the following diseases:
Contact: Cem Gabay, Prof. Dr. | +41 22 3823501 ext +41 22 | cem.gabay@hcuge.ch |
Contact: Carole Medinger, Dr. | +41 22 3823500 ext +41 22 | carole.medinger@hcuge.ch |
Switzerland | |
HUG Hôpitaux Universitaires de Genève | Recruiting |
Genève, Switzerland, 1211 | |
Contact: Cem Gabay, Prof. Dr. +41 22 382 3501 ext +4122 cem.gabay@hcuge.ch | |
Contact: Carole Medinger, Dr. +4122 3823500 ext +4122 carole.medinger@hcuge.ch | |
Principal Investigator: Cem Gabay, Prof. Dr. |
Principal Investigator: | Cem Gabay, Prof. Dr. | HUG Hôpitaux Universitaires de Genève |
Study ID Numbers: | 03CH/Ct06 |
Study First Received: | February 13, 2006 |
Last Updated: | September 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00291499 |
Health Authority: | Switzerland: Swissmedic |
symptomatic OA of the hand |
Musculoskeletal Diseases Osteoarthritis Arthritis Joint Diseases Rheumatic Diseases |