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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.
Full 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
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Inclusion criteria
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:
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
Primary purpose
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Interventional model
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163 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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