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

NCT00312260 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-10-20

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Stephen Brown, MD · The Hospital for Sick Children, Toronto Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-05-31
Completion
2017-03-02

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00312260 on ClinicalTrials.gov