Knee Osteoarthritis Clinical Trial
Official title:
Efficacy and Safety of Glucosamine Sulfate Versus a Pure Analgesic (Acetaminophen/Paracetamol) and Placebo in Patients Suffering From Osteoarthritis of the Knee
Verified date | September 2006 |
Source | Rottapharm |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
The primary objective of this study is to evaluate the efficacy and safety of glucosamine sulfate versus placebo on the symptoms of knee osteoarthritis after 6 months of treatment, using acetaminophen as a reference symptomatic medication.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of knee osteoarthritis according to the clinical and radiological criteria of the American College of Rheumatology (ACR), with minimum symptom severity/characteristics Exclusion Criteria: - Standard exclusions apply |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Portugal | Hospital Universitario de Coimbra | Coimbra | |
Portugal | Hospital Egaz Moniz | Lisboa | |
Portugal | Hospital Conde do Bertiandos | Ponte de Lima | |
Spain | Complejo Hospitalario Juan Canalejo | A Coruña | |
Spain | Hospital Clinic | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Completo Hospitalario de Ciudad Real | Ciudad Real | |
Spain | Fundacíón Jiménez Díaz | Madrid | |
Spain | Hospital de La Pricesa | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Donostia | San Sebastian | |
Spain | Hospital Nuestra Señora de Valme | Sevilla | |
Spain | Hospital Dr. Peset | Valencia |
Lead Sponsor | Collaborator |
---|---|
Rottapharm |
Portugal, Spain,
Herrero-Beaumont G, Román JA, Trabado MC, Blanco FJ, Benito P, Martin-Mola E, et al. Effects of glucosamine sulfate on 6-month control of knee osteoarthritis symptoms vs. placebo and acetaminophen: results from the Glucosamine Unum In Die Efficacy (GUIDE)
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lequesne Index | |||
Secondary | WOMAC Index | |||
Secondary | OARSI Responder Criteria |
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