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

NCT ID: NCT01226615

Last Updated: 2012-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Keywords

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Chondroitin sulphate Knee osteoarthritis Functional Magnetic Resonance Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Chondroitin sulphate

Group Type EXPERIMENTAL

Chondroitin sulphate (Condrosan®)

Intervention Type DRUG

800mg (two capsules of 400mg each) taken once a day for four months

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Two placebo capsules taken once a day for four months.

Interventions

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Chondroitin sulphate (Condrosan®)

800mg (two capsules of 400mg each) taken once a day for four months

Intervention Type DRUG

Placebo

Two placebo capsules taken once a day for four months.

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bioiberica

INDUSTRY

Sponsor Role lead

Responsible Party

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Bioibérica S.A.

Principal Investigators

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Jordi Monfort, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Jesús Pujol, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Locations

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Hospital del Mar

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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CS/IV-RMF-01

Identifier Type: -

Identifier Source: org_study_id