Clinical trial NCT00291499: Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthrosis
Keywords: symptomatic OA of the hand
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2006-02-14
Enrollment: 163
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in Global Spontaneous Pain Intensity of Target Hand
timeFrame: 6 months
measure: Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand
timeFrame: 6 month
Secondary outcomes:
measure: Investigator Global Evaluation on Efficacy
timeFrame: 6 months
measure: Change in Grip Strength
timeFrame: 6 months
measure: Change in Morning Stiffness Duration
timeFrame: 6 months
measure: Consumption of Paracetamol
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: HUG - Hôpitaux universitaires de Genève
name: Cem Gabay, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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