Knee OsteoarthritisPhase 4NCT01226615
Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI)
A Phase 4 study testing Chondroitin sulphate (Condrosan®) in people with Knee Osteoarthritis, run by Bioiberica at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Chondroitin sulphate (Condrosan®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Chondroitin sulphate (Condrosan®), Placebo
- Keywords
- Chondroitin sulphate, Knee osteoarthritis, Functional Magnetic Resonance Imaging
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondroitin sulphate (Condrosan®)Drug
800mg (two capsules of 400mg each) taken once a day for four months
PlaceboDrug
Two placebo capsules taken once a day for four months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Chondroitin sulphate Receives: Drug: Chondroitin sulphate (Condrosan®) |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (4)
Assessment of the reduction of pain by Huskisson VAS
Measured: 4 months
Determination of pain and functional capacity using the Lequesne Algofunctional Index
Measured: 4 months
Use of rescue medication
Measured: 4 months
Assessment of the quality of life of patients by SF-36 Health Questionaire
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jordi Monfort, MD, Principal investigator, Hospital del MarJesús Pujol, MD, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226615
- Sponsor's protocol ID
- CS/IV-RMF-01
- Status last verified
- Oct 2012
- First submitted
- 8 Oct 2010
- Last updated
- 2 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01226615
- Acronym / sponsor ID
- CS/IV-RMF-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Chondroitin sulphate, Knee osteoarthritis, Functional Magnetic Resonance Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Chondroitin sulphate (Condrosan®)Chondroitin sulphate |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chondroitin sulphate (Condrosan®)800mg (two capsules of 400mg each) taken once a day for four months | Drug | 1 |
| PlaceboTwo placebo capsules taken once a day for four months. | Drug | 2 |
Primary outcome
Brain response to pain caused on arthritic knee selected by fMRI
Time frame: 4 months
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 secondary outcomes
Assessment of the reduction of pain by Huskisson VAS
Time frame: 4 months
Determination of pain and functional capacity using the Lequesne Algofunctional Index
Time frame: 4 months
Use of rescue medication
Time frame: 4 months
Assessment of the quality of life of patients by SF-36 Health Questionaire
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Monfort, MD principal investigator
Hospital del Mar
Jesús Pujol, MD principal investigator
Hospital del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chondroitin sulphate (Condrosan®) in people with Knee Osteoarthritis, run by Bioiberica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain response to pain caused on arthritic knee selected by fMRI (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012; AzTrials last refreshed its copy on 8 Nov 2026.