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

NCT00312260 | Completed Phase 3

• 1 other identifier: 1000008259
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Analgesia; Gabapentin; Amitriptyline; Pediatrics

Outcome Measures

Primary Outcomes (1)

• change in child's pain intensity score

  6 weeks

Secondary Outcomes (1)

• change in child's pain-related disability ratings

  6 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: Gabapentin

2

ACTIVE COMPARATOR

Drug: Amitriptyline

Interventions

Gabapentin DRUG

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.

1

Amitriptyline DRUG

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.

2

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age
• Diagnosis of neuropathic pain

You may not qualify if:

• Additional health problems
• Lactose intolerant
• Unable to swallow size 0 gelatin capsules
• Pregnant
• Unable to speak English

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Gabapentin; Amitriptyline

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds

Study Officials

• Stephen Brown, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 7, 2006
• Study Start: April 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: March 2, 2017
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

CA (1)