OsteoarthritisPhase 4NCT00669123
Chondroitin Sulphate Efficay/Safety in Patients With Knee Osteoarthritis and Psoriasis
A Phase 4 study testing Chondroitin sulphate in people with Osteoarthritis and Psoriasis, run by Bioiberica at 2 sites in Spain.
Trial summary
The purpouse of this study is to determine the efficacy and safety of chondroitin sulphate conventional treatment in patients with both knee osteoarthritis and plaque psoriasis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Psoriasis, Joint Diseases
- What is being tested?
- Chondroitin sulphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 2 sitesSpain
- Study dates
- Start not givento not given
- 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 years and older
- 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 1 to 3 according to Kellgren-Lawrence;
- VAS of pain ≥30;
- PASI ≥ 5.
Who cannot join
- Known allergy to chondroitin sulphate;
- Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, psoriatic arthritis, acromegaly, hemochromatosis, Wilson's disease;
- Patients with skin conditions that could interfere in the clinical trial evaluation
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital del Mar
Barcelona, Barcelona, 08003
Instituto Poal de Reumatología
Barcelona, Barcelona, 08022
About this study
Official title: Fase IV Clinical Trial to Evaluate Chondroitin Sulphate Efficacy and Safety in Patients With Knee Osteoarthritis and Psoriasis
The purpouse of this study is to determine the efficacy and safety of chondroitin sulphate conventional treatment in patients with both knee osteoarthritis and plaque psoriasis.
- Being tested
- Chondroitin sulphate, Placebo
- Keywords
- Chondroitin sulphate, Knee osteoarthritis, Psoriasis
- Medical subject headings
- Osteoarthritis, Psoriasis, Joint Diseases, Skin Diseases, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondroitin sulphateDrug
Also called Condrosan
Chondroitin sulphate 800 mg/day
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
| 1 | Experimental | Chondroitin sulphate Receives: Drug: Chondroitin sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Huskisson Visual Analogue Scale
Measured: Monthly
Psoriasis Area and Severity Index
Measured: Monthly
Secondary outcomes (9)
Lequesne Index
Measured: Monthly
Use of rescue medication
Measured: Monthly
SF-36 Health Questionaire
Measured: 3 months
Overall Lession Severity Scale
Measured: Monthly
Physician's Global Assessment of improvement
Measured: Monthly
Histological assessment of skin biopsies
Measured: 3 months
Dermatology Life Quality Index
Measured: Monthly
Tolerability
Measured: Monthly
Adverse events
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pere Benito, MD, Principal investigator, Hospital del MarMontserrat Pérez, MD, Principal investigator, Instituto Poal de ReumatologíaIngrid Möller, MD, Principal investigator, Instituto Poal de Reumatología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669123
- Sponsor's protocol ID
- CS/IV/PSO/ART
- Status last verified
- Apr 2008
- First submitted
- 24 Apr 2008
- Last updated
- 29 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Moller I, Perez M, Monfort J, Benito P, Cuevas J, Perna C, Domenech G, Herrero M, Montell E, Verges J. Effectiveness of chondroitin sulphate in patients with concomitant knee osteoarthritis and psoriasis: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage. 2010 Jun;18 Suppl 1:S32-40. doi: 10.1016/j.joca.2010.01.018. Epub 2010 May 10.
PubMed 20399899
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fase IV Clinical Trial to Evaluate Chondroitin Sulphate Efficacy and Safety in Patients With Knee Osteoarthritis and Psoriasis
- ClinicalTrials.gov ID
- NCT00669123
- Acronym / sponsor ID
- CS/IV/PSO/ART
- Keywords
- Chondroitin sulphate, Knee osteoarthritis, Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- First posted
- 29 Apr 2008 (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 purpouse of this study is to determine the efficacy and safety of chondroitin sulphate conventional treatment in patients with both knee osteoarthritis and plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Placebo |
| 1 | Experimental | Drug: Chondroitin sulphateChondroitin sulphate |
Who may qualify
- Ages
- 40 years and older
- 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 1 to 3 according to Kellgren-Lawrence;
- VAS of pain ≥30;
- PASI ≥ 5.
Key exclusion criteria (3 listed)
- Known allergy to chondroitin sulphate;
- Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, psoriatic arthritis, acromegaly, hemochromatosis, Wilson's disease;
- Patients with skin conditions that could interfere in the clinical trial evaluation
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 sulphateAlso: CondrosanChondroitin sulphate 800 mg/day | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Huskisson Visual Analogue Scale
Time frame: Monthly
Psoriasis Area and Severity Index
Time frame: Monthly
9 secondary outcomes
Lequesne Index
Time frame: Monthly
Use of rescue medication
Time frame: Monthly
SF-36 Health Questionaire
Time frame: 3 months
Overall Lession Severity Scale
Time frame: Monthly
Physician's Global Assessment of improvement
Time frame: Monthly
Histological assessment of skin biopsies
Time frame: 3 months
Dermatology Life Quality Index
Time frame: Monthly
Tolerability
Time frame: Monthly
Adverse events
Time frame: Monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2008.
- Derived from this study: PubMed 20399899Moller I, Perez M, Monfort J, Benito P, Cuevas J, Perna C, Domenech G, Herrero M, Montell E, Verges J. Effectiveness of chondroitin sulphate in patients with concomitant knee osteoarthritis and psoriasis: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage. 2010 Jun;18 Suppl 1:S32-40. doi: 10.1016/j.joca.2010.01.018. Epub 2010 May 10.
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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.
Pere Benito, MD principal investigator
Hospital del Mar
Montserrat Pérez, MD principal investigator
Instituto Poal de Reumatología
Ingrid Möller, MD principal investigator
Instituto Poal de Reumatología
2 sites 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 in people with Osteoarthritis and Psoriasis, run by Bioiberica at 2 sites 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 3 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: finished, as of the sponsor's last update on 29 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Huskisson Visual Analogue Scale (time frame: Monthly). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00669123, which also lists 1 linked publication.
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 29 Apr 2008.