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Status unknownNCT01226615Updated Oct 2, 2012

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

A Phase 4 interventional study of Chondroitin sulphate (Condrosan®) and Placebo in Knee Osteoarthritis, sponsored by Bioiberica. Status unknown at 1 site in Spain. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-10-02.

Sponsored by Bioiberica · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Chondroitin sulphate
  • Knee osteoarthritis
  • Functional Magnetic Resonance Imaging
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 64 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Bioiberica is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    1

    Chondroitin sulphate

    Drug: Chondroitin sulphate (Condrosan®)

  • Placebo comparator
    2

    Placebo

    Drug: Placebo

Interventions

  • DrugChondroitin sulphate (Condrosan®)

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

  • DrugPlacebo

    Two placebo capsules taken once a day for four months.

06

What researchers measure

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.

    Time frame: 4 months

Secondary outcomes

  1. Assessment of the reduction of pain by Huskisson VAS

    Time frame: 4 months

  2. Determination of pain and functional capacity using the Lequesne Algofunctional Index

    Time frame: 4 months

  3. Use of rescue medication

    Time frame: 4 months

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

    Time frame: 4 months

07

Study locations

1 site
  • Hospital del Mar
    Barcelona, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01226615
Lead sponsor
Bioiberica
First posted
Oct 22, 2010
Start date
Oct 2010
Primary completion
Oct 2011
Completion
Dec 2012 (estimated)
Last update
Oct 2, 2012

Study contacts

Jordi Monfort, MD
principal investigator · Hospital del Mar
Jesús Pujol, MD
principal investigator · Hospital del Mar
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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