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

NCT ID: NCT00291499

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2010-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chondroitin 4&6 sulfate (Condrosulf)

Group Type: ACTIVE_COMPARATOR

Chondroitin 4&6 sulfate (Condrosulf)

Intervention Type: DRUG

800 mg/day for 6 months

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

800 mg placebo/day for 6 months

Interventions

Chondroitin 4&6 sulfate (Condrosulf)

800 mg/day for 6 months

Intervention Type: DRUG

Placebo

800 mg placebo/day for 6 months

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IBSA Institut Biochimique SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cem Gabay, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

HUG - Hôpitaux universitaires de Genève

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Other Identifiers

03CH/Ct06

Identifier Type: -

Identifier Source: org_study_id