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

This study has been completed.
Information provided by:
Rottapharm Identifier:
First received: May 9, 2005
Last updated: September 18, 2006
Last verified: September 2006
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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


Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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.

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00110474     History of Changes
Other Study ID Numbers: JN151198
Study First Received: May 9, 2005
Last Updated: September 18, 2006
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Rottapharm:
Glucosamine sulfate
Clinical trial

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 27, 2015