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Completed

NCT Number: NCT00669123

Chondroitin Sulphate Efficay/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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Muskuloskeletal Diseases Osteoarthritis, Knee Psoriasis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital del Mar, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chondroitin sulphate

Drug

Chondroitin sulphate 800 mg/day

Other names: Condrosan

Placebo

Drug

Primary outcomes

  1. Huskisson Visual Analogue Scale

    Time frame: Monthly

  2. Psoriasis Area and Severity Index

    Time frame: Monthly

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bioiberica

Industry

Registry information

Official study title

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

Important dates

First posted
Apr 29, 2008
Registry last updated
Apr 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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