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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01226615
• Other study ID #: CS/IV-RMF-01
• Status: Unknown status
• Phase: Phase 4
• First received: October 8, 2010
• Last updated: October 1, 2012
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: Bioiberica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 64
• Est. completion date: December 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Chondroitin sulphate (Condrosan®)
800mg (two capsules of 400mg each) taken once a day for four months
• Placebo
Two placebo capsules taken once a day for four months.

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Bioiberica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain response to pain caused on arthritic knee selected by fMRI	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.	4 months
Secondary	Assessment of the reduction of pain by Huskisson VAS		4 months
Secondary	Determination of pain and functional capacity using the Lequesne Algofunctional Index		4 months
Secondary	Use of rescue medication		4 months
Secondary	Assessment of the quality of life of patients by SF-36 Health Questionaire		4 months