Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand
Condition: Osteoarthrosis
MeSH terms: Osteoarthritis
Intervention: Chondroitin 4&6 sulfate (Condrosulf); Placebo
Intervention description: 800 mg/day for 6 months; 800 mg placebo/day for 6 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 163.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: symptomatic OA of the hand

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.
    

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