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Chondroitin Sulphate Efficay/Safety in Patients With Knee Osteoarthritis and Psoriasis
This study has been completed.
Sponsor:
Bioiberica
Information provided by:
Bioiberica
ClinicalTrials.gov Identifier:
NCT00669123
First received: April 24, 2008
Last updated: April 28, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Osteoarthritis Psoriasis Joint Diseases Muskuloskeletal Diseases Skin Diseases | Drug: Chondroitin sulphate Drug: Placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Fase IV Clinical Trial to Evaluate Chondroitin Sulphate Efficacy and Safety in Patients With Knee Osteoarthritis and Psoriasis |
Resource links provided by NLM:
Further study details as provided by Bioiberica:
Primary Outcome Measures:
- Huskisson Visual Analogue Scale [ Time Frame: Monthly ]
- Psoriasis Area and Severity Index [ Time Frame: Monthly ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 126 |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 2 | Drug: Placebo |
|
Experimental: 1
Chondroitin sulphate
|
Drug: Chondroitin sulphate
Chondroitin sulphate 800 mg/day
Other Name: Condrosan
|
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669123
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669123
Locations
| Spain | |
| Hospital del Mar | |
| Barcelona, Spain, 08003 | |
| Instituto Poal de Reumatología | |
| Barcelona, Spain, 08022 | |
Sponsors and Collaborators
Bioiberica
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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Josep Vergés Milano, Scientific Medical Director, Bioiberica |
| ClinicalTrials.gov Identifier: | NCT00669123 History of Changes |
| Other Study ID Numbers: |
CS/IV/PSO/ART |
| Study First Received: | April 24, 2008 |
| Last Updated: | April 28, 2008 |
Keywords provided by Bioiberica:
|
Chondroitin sulphate Knee osteoarthritis Psoriasis |
Additional relevant MeSH terms:
|
Osteoarthritis Psoriasis Osteoarthritis, Knee Skin Diseases Joint Diseases |
Arthritis Musculoskeletal Diseases Rheumatic Diseases Skin Diseases, Papulosquamous |
ClinicalTrials.gov processed this record on June 28, 2017