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

This study has been completed.
Sponsor:
Information provided by:
Bioiberica
ClinicalTrials.gov Identifier:
NCT00669123
First received: April 24, 2008
Last updated: April 28, 2008
Last verified: April 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Bioiberica:

Primary Outcome Measures:
  • Huskisson Visual Analogue Scale [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lequesne Index [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Use of rescue medication [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • SF-36 Health Questionaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Overall Lession Severity Scale [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Physician's Global Assessment of improvement [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Histological assessment of skin biopsies [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Dermatology Life Quality Index [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Tolerability [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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
Health Authority: Spain: Ministry of Health

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 September 27, 2016