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Sponsored by: |
Rottapharm |
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Information provided by: | Rottapharm |
ClinicalTrials.gov Identifier: | NCT00110474 |
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.
Condition | Intervention | Phase |
---|---|---|
Knee Osteoarthritis |
Drug: Glucosamine sulfate Drug: Acetaminophen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy and Safety of Glucosamine Sulfate Versus a Pure Analgesic (Acetaminophen/Paracetamol) and Placebo in Patients Suffering From Osteoarthritis of the Knee |
Estimated Enrollment: | 300 |
Study Start Date: | May 2000 |
Estimated Study Completion Date: | December 2002 |
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Portugal | |
Hospital Conde do Bertiandos | |
Ponte de Lima, Portugal | |
Hospital Universitario de Coimbra | |
Coimbra, Portugal | |
Hospital Egaz Moniz | |
Lisboa, Portugal | |
Spain | |
Fundacíón Jiménez Díaz | |
Madrid, Spain | |
Hospital Dr. Peset | |
Valencia, Spain | |
Completo Hospitalario de Ciudad Real | |
Ciudad Real, Spain | |
Hospital Donostia | |
San Sebastian, Spain | |
Hospital Universitario La Paz | |
Madrid, Spain | |
Hospital del Mar | |
Barcelona, Spain | |
Hospital Clinic | |
Barcelona, Spain | |
Hospital Nuestra Señora de Valme | |
Sevilla, Spain | |
Complejo Hospitalario Juan Canalejo | |
A Coruña, Spain | |
Hospital de La Pricesa | |
Madrid, Spain |
Study Director: | Gabriel Herrero-Beaumont, MD | Fundacíón Jiménez Díaz - Madrid - Spain |
Study ID Numbers: | JN151198 |
Study First Received: | May 9, 2005 |
Last Updated: | September 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00110474 |
Health Authority: | Spain: Spanish Agency of Medicines |
Glucosamine sulfate Osteoarthritis Acetaminophen Paracetamol Clinical trial |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Rheumatic Diseases Acetaminophen |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |