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

Osteoarthritis Clinical Trial

Official title:

Fase IV Clinical Trial to Evaluate Chondroitin Sulphate Efficacy and Safety in Patients With Knee Osteoarthritis and Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669123
• Other study ID #: CS/IV/PSO/ART
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2008
• Last updated: April 28, 2008

Study information

• Verified date: April 2008
• Source: Bioiberica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Muskuloskeletal Diseases
• Osteoarthritis
• Osteoarthritis, Knee
• Psoriasis
• Skin Diseases

Intervention

Drug:
• Chondroitin sulphate
Chondroitin sulphate 800 mg/day
• Placebo

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona
Spain	Instituto Poal de Reumatología	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Bioiberica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Huskisson Visual Analogue Scale		Monthly	No
Primary	Psoriasis Area and Severity Index		Monthly	No
Secondary	Lequesne Index		Monthly	No
Secondary	Use of rescue medication		Monthly	No
Secondary	SF-36 Health Questionaire		3 months	No
Secondary	Overall Lession Severity Scale		Monthly	No
Secondary	Physician's Global Assessment of improvement		Monthly	No
Secondary	Histological assessment of skin biopsies		3 months	No
Secondary	Dermatology Life Quality Index		Monthly	No
Secondary	Tolerability		Monthly	Yes
Secondary	Adverse events		Monthly	Yes