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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01226615 |
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Date of registration:
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08/10/2010 |
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Primary sponsor: |
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Public title:
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Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI)
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Scientific title:
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Randomized, Double-blind, Placebo-controlled Study to Asses the Effect of Chondroitin Sulphate in Patients With Knee Osteoarthritis by Functional Magnetic Resonance Imaging |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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64 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01226615 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Spain
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Contacts
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Name:
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Jesús Pujol, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital del Mar |
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Name:
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Jordi Monfort, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital del Mar |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Knee Osteoarthritis
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Intervention(s)
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Drug: Chondroitin sulphate (Condrosan®)
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Drug: Placebo
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Primary Outcome(s)
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Brain response to pain caused on arthritic knee selected by fMRI
[Time Frame: 4 months]
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Secondary Outcome(s)
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Assessment of the quality of life of patients by SF-36 Health Questionaire
[Time Frame: 4 months]
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Assessment of the reduction of pain by Huskisson VAS
[Time Frame: 4 months]
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Determination of pain and functional capacity using the Lequesne Algofunctional Index
[Time Frame: 4 months]
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Use of rescue medication
[Time Frame: 4 months]
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Secondary ID(s)
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CS/IV-RMF-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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