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

Primary Purpose

Osteoarthritis, Psoriasis, Joint Diseases

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Chondroitin sulphate
Placebo
Sponsored by
Bioiberica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Chondroitin sulphate, Knee osteoarthritis, Psoriasis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital del Mar
  • Instituto Poal de Reumatología

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

Chondroitin sulphate

Outcomes

Primary Outcome Measures

Huskisson Visual Analogue Scale
Psoriasis Area and Severity Index

Secondary Outcome Measures

Lequesne Index
Use of rescue medication
SF-36 Health Questionaire
Overall Lession Severity Scale
Physician's Global Assessment of improvement
Histological assessment of skin biopsies
Dermatology Life Quality Index
Tolerability
Adverse events

Full Information

First Posted
April 24, 2008
Last Updated
April 28, 2008
Sponsor
Bioiberica
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1. Study Identification

Unique Protocol Identification Number
NCT00669123
Brief Title
Chondroitin Sulphate Efficay/Safety in Patients With Knee Osteoarthritis and Psoriasis
Official Title
Fase IV Clinical Trial to Evaluate Chondroitin Sulphate Efficacy and Safety in Patients With Knee Osteoarthritis and Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bioiberica

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Psoriasis, Joint Diseases, Muskuloskeletal Diseases, Skin Diseases
Keywords
Chondroitin sulphate, Knee osteoarthritis, Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Title
1
Arm Type
Experimental
Arm Description
Chondroitin sulphate
Intervention Type
Drug
Intervention Name(s)
Chondroitin sulphate
Other Intervention Name(s)
Condrosan
Intervention Description
Chondroitin sulphate 800 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Huskisson Visual Analogue Scale
Time Frame
Monthly
Title
Psoriasis Area and Severity Index
Time Frame
Monthly
Secondary Outcome Measure Information:
Title
Lequesne Index
Time Frame
Monthly
Title
Use of rescue medication
Time Frame
Monthly
Title
SF-36 Health Questionaire
Time Frame
3 months
Title
Overall Lession Severity Scale
Time Frame
Monthly
Title
Physician's Global Assessment of improvement
Time Frame
Monthly
Title
Histological assessment of skin biopsies
Time Frame
3 months
Title
Dermatology Life Quality Index
Time Frame
Monthly
Title
Tolerability
Time Frame
Monthly
Title
Adverse events
Time Frame
Monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere Benito, MD
Organizational Affiliation
Hospital del Mar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Montserrat Pérez, MD
Organizational Affiliation
Instituto Poal de Reumatología
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ingrid Möller, MD
Organizational Affiliation
Instituto Poal de Reumatología
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Instituto Poal de Reumatología
City
Barcelona
ZIP/Postal Code
08022
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20399899
Citation
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.
Results Reference
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Chondroitin Sulphate Efficay/Safety in Patients With Knee Osteoarthritis and Psoriasis

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