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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01226615
Recruitment Status : Unknown
Verified October 2012 by Bioiberica.
Recruitment status was:  Active, not recruiting
First Posted : October 22, 2010
Last Update Posted : October 2, 2012
Information provided by:

Brief Summary:

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 or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Chondroitin sulphate (Condrosan®) Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : October 2010
Actual Primary Completion Date : October 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Chondroitin sulphate
Drug: Chondroitin sulphate (Condrosan®)
800mg (two capsules of 400mg each) taken once a day for four months

Placebo Comparator: 2
Drug: Placebo
Two placebo capsules taken once a day for four months.

Primary Outcome Measures :
  1. Brain response to pain caused on arthritic knee selected by fMRI [ Time Frame: 4 months ]

    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 :
  1. Assessment of the reduction of pain by Huskisson VAS [ Time Frame: 4 months ]
  2. Determination of pain and functional capacity using the Lequesne Algofunctional Index [ Time Frame: 4 months ]
  3. Use of rescue medication [ Time Frame: 4 months ]
  4. Assessment of the quality of life of patients by SF-36 Health Questionaire [ Time Frame: 4 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01226615

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Hospital del Mar
Barcelona, Spain
Sponsors and Collaborators
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Principal Investigator: Jordi Monfort, MD Hospital del Mar
Principal Investigator: Jesús Pujol, MD Hospital del Mar

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Responsible Party: Dr. Josep Vergés, Scientific Medical Director, Bioibérica S.A. Identifier: NCT01226615     History of Changes
Other Study ID Numbers: CS/IV-RMF-01
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: October 2, 2012
Last Verified: October 2012
Keywords provided by Bioiberica:
Chondroitin sulphate
Knee osteoarthritis
Functional Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases