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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 10, 2005
Last Update Posted: September 19, 2006
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.
Information provided by:
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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Rottapharm:

Primary Outcome Measures:
  • Lequesne Index

Secondary Outcome Measures:
  • WOMAC Index
  • OARSI Responder Criteria

Estimated Enrollment: 300
Study Start Date: May 2000
Estimated Study Completion Date: December 2002
  Show Detailed Description


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00110474

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
Study Director: Gabriel Herrero-Beaumont, MD Fundacíón Jiménez Díaz - Madrid - Spain
  More Information

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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00110474     History of Changes
Other Study ID Numbers: JN151198
First Submitted: May 9, 2005
First Posted: May 10, 2005
Last Update Posted: September 19, 2006
Last Verified: September 2006

Keywords provided by Rottapharm:
Glucosamine sulfate
Clinical trial

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs