Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents

October 19, 2020 updated by: Stephen Brown, The Hospital for Sick Children

Randomized Controlled Trial Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Gabapentin
Gabapentin will be prescribed at 900mg/d (300mg tid). A dose escalation schedule will be followed: one pill taken at night (~2000h) for the first 3 days, one pill at night and one pill in the morning (~0800h) for the second 3 days and finally, one pill at night, one in the morning and one mid-afternoon (~1400h) for the reminder of the trial.
Active Comparator: 2
Drug: Amitriptyline
Amitriptyline will be prescribed at a dose of 10mg (qhs). A dose escalation schedule will be followed: one pill taken at night (~2000h) for the first 3 days, one pill at night and one pill in the morning (~0800h) for the second 3 days and finally, one pill at night, one in the morning and one mid-afternoon (~1400h) for the reminder of the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in child's pain intensity score
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
change in child's pain-related disability ratings
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Stephen Brown, MD, The Hospital for Sick Children, Toronto Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

March 2, 2017

Study Registration Dates

First Submitted

April 5, 2006

First Submitted That Met QC Criteria

April 6, 2006

First Posted (Estimate)

April 7, 2006

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000008259

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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