Chondroitin Sulphate Efficay/Safety in Patients With Knee Osteoarthritis and Psoriasis - Full Text View

Sponsor:	Bioiberica
Information provided by:	Bioiberica
ClinicalTrials.gov Identifier:	NCT00669123

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis Psoriasis Joint Diseases Muskuloskeletal Diseases Skin Diseases	Drug: Chondroitin sulphate Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Fase IV Clinical Trial to Evaluate Chondroitin Sulphate Efficacy and Safety in Patients With Knee Osteoarthritis and Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Joint Disorders Osteoarthritis Psoriasis Skin Conditions

Drug Information available for: Translagen Chondroitin Chondroitin sulfates

U.S. FDA Resources

Further study details as provided by Bioiberica:

Primary Outcome Measures:

Huskisson Visual Analogue Scale [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Psoriasis Area and Severity Index [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lequesne Index [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Use of rescue medication [ Time Frame: Monthly ] [ Designated as safety issue: No ]
SF-36 Health Questionaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Overall Lession Severity Scale [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Physician's Global Assessment of improvement [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Histological assessment of skin biopsies [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Dermatology Life Quality Index [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Tolerability [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Enrollment:

126

Arms	Assigned Interventions
2: Placebo Comparator	Drug: Placebo
1: Experimental Chondroitin sulphate	Drug: Chondroitin sulphate Chondroitin sulphate 800 mg/day

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669123

Locations

Spain
Hospital del Mar
Barcelona, Spain, 08003
Instituto Poal de Reumatología
Barcelona, Spain, 08022

Sponsors and Collaborators

Bioiberica

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

More Information

No publications provided

Responsible Party:	Bioiberica ( Dr Josep Vergés Milano, Scientific Medical Director )
Study ID Numbers:	CS/IV/PSO/ART
Study First Received:	April 24, 2008
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00669123 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by Bioiberica:

Chondroitin sulphate
Knee osteoarthritis
Psoriasis

Additional relevant MeSH terms:

Osteoarthritis, Knee
Musculoskeletal Diseases
Skin Diseases
Psoriasis
Osteoarthritis

Arthritis
Joint Diseases
Rheumatic Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on February 08, 2010