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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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

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

Conditions
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Osteoarthrosis

Intervention / Treatment
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* Drug: Chondroitin 4&6 sulfate (Condrosulf)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chondroitin 4&6 sulfate (Condrosulf)<br> | Drug: Chondroitin 4&6 sulfate (Condrosulf)<br>* 800 mg/day for 6 months<br>|
| Placebo Comparator: placebo<br> | Other: Placebo<br>* 800 mg placebo/day for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Global Spontaneous Pain Intensity of Target Hand | Intensity of global spontaneous pain is evaluated by the patient himself on a Huskisson's visual analogue scale (VAS) of 100 mm. 0=no pain 100=max pain Change calculated as difference between Month 6 value and baseline value target hand is defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand. | 6 months | 
| Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand | Functional Index for Hand Osteoarthritis (Dreiser's Index). Range 0-30 Patients reported the severity of their symptoms by answering a set of 10 questions. Severity was rated on a numerical scale (0 = possible without difficulty, 1 = possible with slight difficulty, 2 =possible with great difficulty, and 3 = impossible), being 30 points the worst possible pain score. Change calculated as difference between the month 6 value and baseline value Target hand defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Evaluation on Efficacy | Global impression of the efficacy judged by the Investigators at month 6 by means of a visual analogue scale from 0 (no efficacy) to 100 mm (very good efficacy) | 6 months | 
| Change in Grip Strength | Grip strength determined on both hands using a Jamar dynamometer.Patients were required to grip the dynamometer handle and squeeze as hard as possible according to their individual pain limits. The right hand grip was measured first, then the left; this procedure was performed 3 times. The mean value of these 3 measurements was recorded. Change calculated as difference between the month 6 value and baseline value | 6 months | 
| Change in Morning Stiffness Duration | Change in morning stiffness duration calculated as the difference between the month 6 value and the baseline value | 6 months | 
| Consumption of Paracetamol | Total consumption (between ^baseline and month 6) of paracetamol (500 mg tablets) reported by the patients on a daily diary | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symptomatic OA of the hand