Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Pain |
| Intervention | Drug: Gabapentin Drug: Amitriptyline |
| Phase | Phase 3 |
| Sponsor | The Hospital for Sick Children |
| Responsible Party | The Hospital for Sick Children |
| ClinicalTrials.gov Identifier | NCT00312260 |
| First Received | April 5, 2006 |
| Last Updated | December 13, 2010 |
| Last verified | December 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 5, 2006 |
|---|---|
| Last Updated Date | December 13, 2010 |
| Start Date | April 2006 |
| Estimated Primary Completion Date | December 2010 |
| Current Primary Outcome Measures | change in child's pain intensity score [Time Frame: 6 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | change in child's pain-related disability ratings [Time Frame: 6 weeks] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents |
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| Official Title | Randomized Controlled Trial Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents |
| 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. |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Pain |
| Intervention | 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. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
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| Estimated Enrollment | 40 |
| Estimated Completion Date | December 2010 |
| Estimated Primary Completion Date | May 2010 |
| Eligibility 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 |
| Gender | Both |
| Ages | 8 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00312260 |
|---|---|
| Other Study ID Numbers | 1000008259 |
| Has Data Monitoring Committee | No |
| Information Provided By | The Hospital for Sick Children |
| Study Sponsor | The Hospital for Sick Children |
| Collaborators | Canadian Institutes of Health Research (CIHR) |
| Investigators | Principal Investigator: Patricia McGrath, PhD The Hospital for Sick Children, Toronto Canada |
| Verification Date | December 2010 |
Locations[ + expand ][ + ]
| The Hospital for Sick Children | Toronto, Ontario, Canada, M5G 1X8 |
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