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Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Bioiberica
ClinicalTrials.gov Identifier:
NCT01226615
First received: October 8, 2010
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

The main purposes of this study are:

  • to determine the effects of chondroitin sulphate on brain response to pain assessed through fMRI in patients with knee osteoarthritis.
  • to investigate the relationship between treatment response detected by fMRI and the results of the different parameters of clinical assessment.

Condition Intervention Phase
Knee Osteoarthritis
 Drug: Chondroitin sulphate (Condrosan®)
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Study to Asses the Effect of Chondroitin Sulphate in Patients With Knee Osteoarthritis by Functional Magnetic Resonance Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bioiberica:

Primary Outcome Measures:
  • Brain response to pain caused on arthritic knee selected by fMRI [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    Functional magnetic resonance imaging (fMRI) is particularly suited to investigating the effects of pharmacological agents on pain processing within the human central nervous system.

    The measures are based on the haemodynamic resonse to a neuronal event and constitute indirect measures of excitatory and inhibitory neuronal activity. The neuronal activation is associated with an increase of the oxygen extraction fraction from the capillaries and with an increase in regional cerebral blood flow. The measure which derived from blood oxygenation is called the BOLD effect.



Secondary Outcome Measures:
  • Assessment of the reduction of pain by Huskisson VAS [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Determination of pain and functional capacity using the Lequesne Algofunctional Index [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Use of rescue medication [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Assessment of the quality of life of patients by SF-36 Health Questionaire [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Chondroitin sulphate
 Drug: Chondroitin sulphate (Condrosan®)
800mg (two capsules of 400mg each) taken once a day for four months
Placebo Comparator: 2
Placebo
 Drug: Placebo
Two placebo capsules taken once a day for four months.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary knee OA according to ACR criteria
  • OA of radiological stages 2 to 3 according to Kellgren-Lawrence
  • Estable knee pain during the last months before to start the clinical trial
  • Patients with pain as the VAS≥50mm at baseline

Exclusion Criteria:

  • Patients with skin conditions that could interfere in the clinical trial evaluation
  • Pregnant or breastfeeding woman
  • Patients with a history of alcoholism or other drug abuse
  • Patients with an uncontrolled active psychiatric disorder
  • Patients with other inflammatory or systemic conditions affecting other joints
  • Patients who suffer more intense pain in the joint in another location
  • Patients unable to differentiate between symptoms caused by the knee in front of the joint study opposite
  • OA of radiological stages 1 or 4 according to Kellgren-Lawrence
  • Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis
  • Patients with contraindications to perform an MRI such as: certain tattoos, pacemakers, intracranial clips incompatible with MRI, in the heart valves, hearing aids and other types of implants are incompatible with MRI
  • Known allergy to chondroitin sulphate
  • Washout period for OA treatments before beginning the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226615

Locations
Spain
Hospital del Mar
Barcelona, Spain
Sponsors and Collaborators
Bioiberica
Investigators
Principal Investigator: Jordi Monfort, MD Hospital del Mar
Principal Investigator: Jesús Pujol, MD Hospital del Mar
  More Information

No publications provided

Responsible Party: Dr. Josep Vergés, Scientific Medical Director, Bioibérica S.A.
ClinicalTrials.gov Identifier: NCT01226615     History of Changes
Other Study ID Numbers: CS/IV-RMF-01
Study First Received: October 8, 2010
Last Updated: October 1, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Bioiberica:
Chondroitin sulphate
Knee osteoarthritis
Functional Magnetic Resonance Imaging

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

ClinicalTrials.gov processed this record on May 23, 2013