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

NCT01226615 | Unknown Phase 4

• 1 other identifier: CS/IV-RMF-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Chondroitin sulphate; Knee osteoarthritis; Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of the reduction of pain by Huskisson VAS

  4 months

• Determination of pain and functional capacity using the Lequesne Algofunctional Index

  4 months

• Use of rescue medication

  4 months

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

  4 months

Study Arms (2)

1

EXPERIMENTAL

Chondroitin sulphate

Drug: Chondroitin sulphate (Condrosan®)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Chondroitin sulphate (Condrosan®) DRUG

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

1

Placebo DRUG

Two placebo capsules taken once a day for four months.

2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioiberica: lead

Study Sites (1)

Hospital del Mar

Barcelona, Barcelona, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Chondroitin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Jordi Monfort, MD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

• Jesús Pujol, MD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 22, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2012
• Last Updated: October 2, 2012

Record last verified: 2012-10

Locations

ES (1)