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Glucosamine Unum In Die [Once A Day] Efficacy (GUIDE) Trial: Glucosamine Sulfate in Patients With Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110474
Recruitment Status : Completed
First Posted : May 10, 2005
Last Update Posted : September 19, 2006
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Glucosamine sulfate Drug: Acetaminophen Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Glucosamine Sulfate Versus a Pure Analgesic (Acetaminophen/Paracetamol) and Placebo in Patients Suffering From Osteoarthritis of the Knee
Study Start Date : May 2000
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Primary Outcome Measures :
  1. Lequesne Index

Secondary Outcome Measures :
  1. WOMAC Index
  2. OARSI Responder Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110474

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Hospital Universitario de Coimbra
Coimbra, Portugal
Hospital Egaz Moniz
Lisboa, Portugal
Hospital Conde do Bertiandos
Ponte de Lima, Portugal
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, Spain
Sponsors and Collaborators
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Study Director: Gabriel Herrero-Beaumont, MD Fundacíón Jiménez Díaz - Madrid - Spain
Publications of Results:
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) trial [abstract]. Arthritis Rheum 2005;9 Suppl: 1203.

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00110474    
Other Study ID Numbers: JN151198
First Posted: May 10, 2005    Key Record Dates
Last Update Posted: September 19, 2006
Last Verified: September 2006
Keywords provided by Rottapharm:
Glucosamine sulfate
Clinical trial
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs