- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00669123
Chondroitin Sulphate Efficay/Safety in Patients With Knee Osteoarthritis and Psoriasis
April 28, 2008 updated by: Bioiberica
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08003
- Hospital del Mar
-
Barcelona, Spain, 08022
- Instituto Poal de Reumatología
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary knee OA according to ACR criteria;
- OA of radiological stages 1 to 3 according to Kellgren-Lawrence;
- VAS of pain ≥30;
- PASI ≥ 5.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
|
Experimental: 1
Chondroitin sulphate
|
Chondroitin sulphate 800 mg/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Huskisson Visual Analogue Scale
Time Frame: Monthly
|
Monthly
|
Psoriasis Area and Severity Index
Time Frame: Monthly
|
Monthly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lequesne Index
Time Frame: Monthly
|
Monthly
|
Use of rescue medication
Time Frame: Monthly
|
Monthly
|
SF-36 Health Questionaire
Time Frame: 3 months
|
3 months
|
Overall Lession Severity Scale
Time Frame: Monthly
|
Monthly
|
Physician's Global Assessment of improvement
Time Frame: Monthly
|
Monthly
|
Histological assessment of skin biopsies
Time Frame: 3 months
|
3 months
|
Dermatology Life Quality Index
Time Frame: Monthly
|
Monthly
|
Tolerability
Time Frame: Monthly
|
Monthly
|
Adverse events
Time Frame: Monthly
|
Monthly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pere Benito, MD, Hospital del Mar
- Principal Investigator: Montserrat Pérez, MD, Instituto Poal de Reumatología
- Principal Investigator: Ingrid Möller, MD, Instituto Poal de Reumatología
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 24, 2008
First Submitted That Met QC Criteria
April 28, 2008
First Posted (Estimate)
April 29, 2008
Study Record Updates
Last Update Posted (Estimate)
April 29, 2008
Last Update Submitted That Met QC Criteria
April 28, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS/IV/PSO/ART
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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