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

This study has been completed.

First Received: May 9, 2005 Last Updated: September 18, 2006 History of Changes

Sponsor:	Rottapharm
Information provided by:	Rottapharm
ClinicalTrials.gov Identifier:	NCT00110474

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 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Glucosamine hydrochloride Glucosamine sulfate Acetaminophen CT 2584 Glucosamine

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 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

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 National Clinical Trials Identifier (NCT ID):

Herrero-Beaumont G, Ivorra JA, Del Carmen Trabado M, Blanco FJ, Benito P, Martin-Mola E, Paulino J, Marenco JL, Porto A, Laffon A, Araujo D, Figueroa M, Branco J. Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator. Arthritis Rheum. 2007 Feb;56(2):555-67.

Study ID Numbers:	JN151198
Study First Received:	May 9, 2005
Last Updated:	September 18, 2006
ClinicalTrials.gov Identifier:	NCT00110474 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Rottapharm:

Glucosamine sulfate
Osteoarthritis
Acetaminophen
Paracetamol
Clinical trial

Additional relevant MeSH terms:

Osteoarthritis
Joint Diseases
Physiological Effects of Drugs
Rheumatic Diseases
Pharmacologic Actions
Osteoarthritis, Knee
Musculoskeletal Diseases
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Arthritis
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010