Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents
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ClinicalTrials.gov Identifier: NCT00312260 |
Recruitment Status :
Completed
First Posted : April 7, 2006
Last Update Posted : October 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Drug: Gabapentin Drug: Amitriptyline | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 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 |
Actual Study Completion Date : | March 2, 2017 |

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. |
- change in child's pain intensity score [ Time Frame: 6 weeks ]
- change in child's pain-related disability ratings [ Time Frame: 6 weeks ]

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Ages Eligible for Study: | 8 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 |
Principal Investigator: | Stephen Brown, MD | The Hospital for Sick Children, Toronto Canada |
Responsible Party: | Stephen Brown, Staff Anesthesiologist, The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00312260 |
Other Study ID Numbers: |
1000008259 |
First Posted: | April 7, 2006 Key Record Dates |
Last Update Posted: | October 20, 2020 |
Last Verified: | October 2020 |
Pain Analgesia Gabapentin Amitriptyline Pediatrics |
Amitriptyline Amitriptyline, perphenazine drug combination Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations 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 Adrenergic Agents |