NCT00669123

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
Last Updated

April 29, 2008

Status Verified

April 1, 2008

First QC Date

April 24, 2008

Last Update Submit

April 28, 2008

Conditions

OsteoarthritisPsoriasisJoint DiseasesMuskuloskeletal DiseasesSkin Diseases

Keywords

Chondroitin sulphateKnee osteoarthritisPsoriasis

Outcome Measures

Primary Outcomes (2)

  • Huskisson Visual Analogue Scale

    Monthly

  • Psoriasis Area and Severity Index

    Monthly

Secondary Outcomes (9)

  • Lequesne Index

    Monthly

  • Use of rescue medication

    Monthly

  • SF-36 Health Questionaire

    3 months

  • Overall Lession Severity Scale

    Monthly

  • Physician's Global Assessment of improvement

    Monthly

  • +4 more secondary outcomes

Study Arms (2)

2

PLACEBO COMPARATOR
Drug: Placebo

1

EXPERIMENTAL

Chondroitin sulphate

Drug: Chondroitin sulphate

Interventions

Chondroitin sulphateDRUG

Chondroitin sulphate 800 mg/day

Also known as: Condrosan
1
PlaceboDRUG
2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary knee OA according to ACR criteria;
  • OA of radiological stages 1 to 3 according to Kellgren-Lawrence;
  • VAS of pain ≥30;
  • PASI ≥ 5.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Instituto Poal de Reumatología

Barcelona, Barcelona, 08022, Spain

Location

Related Publications (1)

  • Moller I, Perez M, Monfort J, Benito P, Cuevas J, Perna C, Domenech G, Herrero M, Montell E, Verges J. Effectiveness of chondroitin sulphate in patients with concomitant knee osteoarthritis and psoriasis: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage. 2010 Jun;18 Suppl 1:S32-40. doi: 10.1016/j.joca.2010.01.018. Epub 2010 May 10.

    PMID: 20399899DERIVED

MeSH Terms

Conditions

OsteoarthritisPsoriasisJoint DiseasesSkin DiseasesOsteoarthritis, Knee

Interventions

Chondroitin

Condition Hierarchy (Ancestors)

ArthritisMusculoskeletal DiseasesRheumatic DiseasesSkin Diseases, PapulosquamousSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Pere Benito, MD

    Hospital del Mar

    PRINCIPAL INVESTIGATOR

  • Montserrat Pérez, MD

    Instituto Poal de Reumatología

    PRINCIPAL INVESTIGATOR

  • Ingrid Möller, MD

    Instituto Poal de Reumatología

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 29, 2008

Last Updated

April 29, 2008

Record last verified: 2008-04

Locations

ES(2)