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

Status: Completed
Study State Date: June 2005
Primary Completion Date: Actual December 2009
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Phase: Phase 3

Sponsor(s):
IBSA Institut Biochimique SA
 
Information By: IBSA Institut Biochimique SA
Trial Identifier: NCT00291499
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

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. 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.

+ Additional Objectives Detail

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



Accepts Healthy Volunteers?: No
Enrollment: 162 Actual
Minimum Age: 40 Years
Maximum Age: N/A
Gender(s): Both
Additional Criteria:  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 (< 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 displasias - Intra-articular injection in a hand joint from less than 3 months - Basic treatment of arthritis with symptom-modifying agents (chondroitin sulfate, glucosamine sulfate, diacerrhein, 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

Conditions:
Osteoarthritis
Joint Diseases
Osteoarthrosis
Interventions:
Drug: Chondroitin 4&6 sulfate (Condrosulf)
Other: Placebo
 
Primary Outcome Measures:
Intensity of global spontaneous pain for both hands is evaluated by the patient himself on a Huskisson's visual analogue scale (VAS) of 100 mm and the score of Dreiser's algo-functional index (FIHOA).
Time Frame: 6 months
Safety Issue: No

 
Secondary Outcome Measures:
Global impression of efficacy.
Time Frame: 6 months
Safety Issue: No

Grip strength measured manometrically.
Time Frame: 6 months
Safety Issue: No

Morning stiffness duration
Time Frame: 6 months
Safety Issue: No

Consupmtion of paracetamol
Time Frame: 6 months
Safety Issue: No

Tolerability
Time Frame: 6 months
Safety Issue: Yes

Adverse events
Time Frame: 6 months
Safety Issue: Yes

Treatment compliance
Time Frame: 6 months
Safety Issue: No

Biological markers of arthritis
Time Frame: 6 months
Safety Issue: No

 
Patient Groups:
Assigned Interventions:

Chondroitin 4&6 sulfate (Condrosulf): Active Comparator
Drug: Chondroitin 4&6 sulfate (Condrosulf)
800 mg/day for 6 months

 
placebo: Placebo Comparator
Other: Placebo
800 mg placebo/day for 6 months

 


Investigators:
Principal Investigator: Cem Gabay, Prof. Dr., HUG Hôpitaux Universitaires de Genève


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