Status:
COMPLETED
Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand
Lead Sponsor:
IBSA Institut Biochimique SA
Conditions:
Osteoarthrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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. Primar...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00291499
Start Date
June 1 2005
End Date
August 1 2010
Last Update
March 4 2021
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