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

Primary Purpose

Knee Osteoarthritis

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Chondroitin sulphate (Condrosan®)

Placebo

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Chondroitin sulphate, Knee osteoarthritis, Functional Magnetic Resonance Imaging

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital del Mar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Chondroitin sulphate

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Assessment of the reduction of pain by Huskisson VAS

Determination of pain and functional capacity using the Lequesne Algofunctional Index

Use of rescue medication

Assessment of the quality of life of patients by SF-36 Health Questionaire

Full Information

NCT ID

NCT01226615

First Posted

October 8, 2010

Last Updated

October 1, 2012

Sponsor

Bioiberica

1. Study Identification

Unique Protocol Identification Number

NCT01226615

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Bioiberica

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

Chondroitin sulphate, Knee osteoarthritis, Functional Magnetic Resonance Imaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Chondroitin sulphate

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Chondroitin sulphate (Condrosan®)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Two placebo capsules taken once a day for four months.

Primary Outcome Measure Information:

Title

Brain response to pain caused on arthritic knee selected by fMRI

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Assessment of the reduction of pain by Huskisson VAS

Time Frame

4 months

Title

Determination of pain and functional capacity using the Lequesne Algofunctional Index

Time Frame

4 months

Title

Use of rescue medication

Time Frame

4 months

Title

Assessment of the quality of life of patients by SF-36 Health Questionaire

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jordi Monfort, MD

Organizational Affiliation

Hospital del Mar

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jesús Pujol, MD

Organizational Affiliation

Hospital del Mar

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital del Mar

City

Barcelona

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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