Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents
Information source: The Hospital for Sick Children
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Gabapentin (Drug); Amitriptyline (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s):
Patricia McGrath, PhD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada
Overall contact:
Eric Crawford, Phone: 416-813-7654, Ext: 2373, Email: eric.crawford@sickkids.ca
Summary
The objective of the study is to compare the efficacy of gabapentin and amitriptyline for
treating neuropathic pain in children in a randomized controlled trial.
Clinical Details
Official title: Randomized Controlled Trial Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: change in child's pain intensity score
Secondary outcome: change in child's pain-related disability ratings
Detailed description:
Clinical experience and case reports suggest that both amitriptyline and gabapentin are
effective treatments for neuropathic pain in children; however we do not know which drug is
more effective for specific pain conditions or for specific children. This study will be the
first prospective, randomized double-blind controlled trial directly comparing gabapentin
and amitriptyline for the treatment of neuropathic pain in a paediatric population. We will
also study the time course for pain reduction and evaluate changes in children's physical
function, mood, and sleep. This information is needed to determine which drug is better for
which children and which pain conditions.
Eligibility
Minimum age: 8 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 8 - 17 years of age
- Diagnosis of neuropathic pain
Exclusion Criteria:
- Additional health problems
- Lactose intolerant
- Unable to swallow size 0 gelatin capsules
- Pregnant
- Unable to speak English
Locations and Contacts
Eric Crawford, Phone: 416-813-7654, Ext: 2373, Email: eric.crawford@sickkids.ca
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Patricia McGrath, PhD, Phone: 416 813 6467, Email: patricia.mcgrath@sickkids.ca
Patricia McGrath, PhD, Principal Investigator
Stephen Brown, MD, Sub-Investigator
Fiona Campbell, MD, Sub-Investigator
Petroz Guy, MD, Sub-Investigator
Laura Abbott, MSc, Sub-Investigator
Additional Information
Starting date: April 2006
Last updated: May 27, 2008
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