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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 24, 2014