Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents - Full Text View

Sponsor:	The Hospital for Sick Children
Collaborator:	Canadian Institutes of Health Research (CIHR)
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00312260

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Gabapentin Drug: Amitriptyline	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Randomized Controlled Trial Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents

Resource links provided by NLM:

Drug Information available for: Amitriptyline Gabapentin Gabapentin enacarbil Amitriptyline hydrochloride Triavil

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

change in child's pain intensity score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in child's pain-related disability ratings [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312260

Locations

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

Sponsors and Collaborators

The Hospital for Sick Children

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:

Patricia McGrath, PhD

The Hospital for Sick Children, Toronto Canada

More Information

No publications provided

Responsible Party:	Patricia McGrath, The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00312260 History of Changes
Other Study ID Numbers:	1000008259
Study First Received:	April 5, 2006
Last Updated:	December 13, 2010
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

Pain
Analgesia
Gabapentin
Amitriptyline
Pediatrics

Additional relevant MeSH terms:

Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Amitriptyline
Gabapentin
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Anticonvulsants

ClinicalTrials.gov processed this record on February 09, 2012