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Chondroitin Sulphate Efficay/Safety in Patients With Knee Osteoarthritis and Psoriasis

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ClinicalTrials.gov Identifier: NCT00669123
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : April 29, 2008
Sponsor:
Information provided by:
Bioiberica

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Psoriasis Joint Diseases Muskuloskeletal Diseases Skin Diseases Drug: Chondroitin sulphate Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 2 Drug: Placebo
Experimental: 1
Chondroitin sulphate
 Drug: Chondroitin sulphate
Chondroitin sulphate 800 mg/day
Other Name: Condrosan


Outcome Measures
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Primary Outcome Measures :
  1. Huskisson Visual Analogue Scale [ Time Frame: Monthly ]
  2. Psoriasis Area and Severity Index [ Time Frame: Monthly ]

Secondary Outcome Measures :
  1. Lequesne Index [ Time Frame: Monthly ]
  2. Use of rescue medication [ Time Frame: Monthly ]
  3. SF-36 Health Questionaire [ Time Frame: 3 months ]
  4. Overall Lession Severity Scale [ Time Frame: Monthly ]
  5. Physician's Global Assessment of improvement [ Time Frame: Monthly ]
  6. Histological assessment of skin biopsies [ Time Frame: 3 months ]
  7. Dermatology Life Quality Index [ Time Frame: Monthly ]
  8. Tolerability [ Time Frame: Monthly ]
  9. Adverse events [ Time Frame: Monthly ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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 contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669123


Locations
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Spain
Hospital del Mar
Barcelona, Spain, 08003
Instituto Poal de Reumatología
Barcelona, Spain, 08022
Sponsors and Collaborators
Bioiberica
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Josep Vergés Milano, Scientific Medical Director, Bioiberica
ClinicalTrials.gov Identifier: NCT00669123    
Other Study ID Numbers: CS/IV/PSO/ART
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: April 29, 2008
Last Verified: April 2008
Keywords provided by Bioiberica:
Chondroitin sulphate
Knee osteoarthritis
Psoriasis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Psoriasis
Skin Diseases
 Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Skin Diseases, Papulosquamous