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Trial record 32 of 135 for:    AMITRIPTYLINE

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

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ClinicalTrials.gov Identifier: NCT00312260
Recruitment Status : Unknown
Verified April 2016 by Stephen Brown, The Hospital for Sick Children.
Recruitment status was:  Active, not recruiting
First Posted : April 7, 2006
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Stephen Brown, The Hospital for Sick Children

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Gabapentin Drug: Amitriptyline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents
Study Start Date : April 2006
Actual Primary Completion Date : May 2010
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. change in child's pain intensity score [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. change in child's pain-related disability ratings [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312260


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

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Responsible Party: Stephen Brown, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00312260     History of Changes
Other Study ID Numbers: 1000008259
First Posted: April 7, 2006    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Keywords provided by Stephen Brown, The Hospital for Sick Children:
Pain
Analgesia
Gabapentin
Amitriptyline
Pediatrics
Additional relevant MeSH terms:
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Amitriptyline
Amitriptyline, perphenazine drug combination
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Analgesics, Non-Narcotic
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators