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

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IBSA

Status and phase

Completed
Phase 3

Conditions

Osteoarthrosis

Treatments

Other: Placebo
Drug: Chondroitin 4&6 sulfate (Condrosulf)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00291499
03CH/Ct06

Details and patient eligibility

About

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

Enrollment

163 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

163 participants in 2 patient groups, including a placebo group

Chondroitin 4&6 sulfate (Condrosulf)
Active Comparator group
Treatment:
Drug: Chondroitin 4&6 sulfate (Condrosulf)
placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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