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

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:
  • Condrosan

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

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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