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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT00291499
First received: February 13, 2006
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Osteoarthrosis
Drug: Chondroitin 4&6 sulfate (Condrosulf)
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • Intensity of global spontaneous pain for both hands is evaluated by the patient himself on a Huskisson's visual analogue scale (VAS) of 100 mm and the score of Dreiser's algo-functional index (FIHOA). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global impression of efficacy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Grip strength measured manometrically. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Morning stiffness duration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Consupmtion of paracetamol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Treatment compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Biological markers of arthritis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: June 2005
Study Completion Date: August 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chondroitin 4&6 sulfate (Condrosulf) Drug: Chondroitin 4&6 sulfate (Condrosulf)
800 mg/day for 6 months
Placebo Comparator: placebo Other: Placebo
800 mg placebo/day for 6 months

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of either sex
  • Aged 40 and over
  • Outpatients
  • Patients fulfilling the 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 displasias
  • Intra-articular injection in a hand joint from less than 3 months
  • Basic treatment of arthritis with symptom-modifying agents (chondroitin sulfate, glucosamine sulfate, diacerrhein, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291499

Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
Principal Investigator: Cem Gabay, Prof. Dr. HUG Hôpitaux Universitaires de Genève
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT00291499     History of Changes
Other Study ID Numbers: 03CH/Ct06
Study First Received: February 13, 2006
Last Updated: November 27, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by IBSA Institut Biochimique SA:
symptomatic OA of the hand

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014