Glucosamine Unum In Die [Once A Day] Efficacy (GUIDE) Trial: Glucosamine Sulfate in Patients With Knee Osteoarthritis
Efficacy and Safety of Glucosamine Sulfate Versus a Pure Analgesic (Acetaminophen/Paracetamol) and Placebo in Patients Suffering From Osteoarthritis of the Knee
1 other identifier
interventional
300
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 knee-osteoarthritis
Started May 2000
Typical duration for phase_3 knee-osteoarthritis
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 9, 2005
CompletedFirst Posted
Study publicly available on registry
May 10, 2005
CompletedSeptember 19, 2006
September 1, 2006
May 9, 2005
September 18, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lequesne Index
Secondary Outcomes (2)
WOMAC Index
OARSI Responder Criteria
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of knee osteoarthritis according to the clinical and radiological criteria of the American College of Rheumatology (ACR), with minimum symptom severity/characteristics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rottapharmlead
Study Sites (13)
Hospital Universitario de Coimbra
Coimbra, Portugal
Hospital Egaz Moniz
Lisbon, 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
Hospital Donostia
Donostia / San Sebastian, Spain
Fundacíón Jiménez Díaz
Madrid, Spain
Hospital de La Pricesa
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Nuestra Señora de Valme
Seville, Spain
Hospital Dr. Peset
Valencia, Spain
Related Publications (2)
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.
RESULTHerrero-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. doi: 10.1002/art.22371.
PMID: 17265490DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gabriel Herrero-Beaumont, MD
Fundacíón Jiménez Díaz - Madrid - Spain
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 9, 2005
First Posted
May 10, 2005
Study Start
May 1, 2000
Study Completion
December 1, 2002
Last Updated
September 19, 2006
Record last verified: 2006-09