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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.
Sponsor:
Information provided by:
Rottapharm
ClinicalTrials.gov Identifier:
NCT00110474
First received: May 9, 2005
Last updated: September 18, 2006
Last verified: September 2006
History of Changes
  Purpose

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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110474

Locations
Portugal
Hospital Universitario de Coimbra
Coimbra, Portugal
Hospital Egaz Moniz
Lisboa, Portugal
Hospital Conde do Bertiandos
Ponte de Lima, Portugal
Spain
Complejo Hospitalario Juan Canalejo
A Coruña, Spain
Hospital del Mar
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Completo Hospitalario de Ciudad Real
Ciudad Real, Spain
Hospital Universitario La Paz
Madrid, Spain
Fundacíón Jiménez Díaz
Madrid, Spain
Hospital de La Pricesa
Madrid, Spain
Hospital Donostia
San Sebastian, Spain
Hospital Nuestra Señora de Valme
Sevilla, Spain
Hospital Dr. Peset
Valencia, Spain
Sponsors and Collaborators
Rottapharm
Investigators
Study Director: Gabriel Herrero-Beaumont, MD Fundacíón Jiménez Díaz - Madrid - Spain
  More Information

Publications:
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 ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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
Osteoarthritis
Acetaminophen
Paracetamol
Clinical trial

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Antipyretics
 Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013