Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 135 for:    AMITRIPTYLINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 5, 2006
First Posted Date  ICMJE April 7, 2006
Last Update Posted Date April 27, 2016
Study Start Date  ICMJE April 2006
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2008)
change in child's pain intensity score [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2006)
change in child’s pain intensity score from baseline to 6 week assessment.
Change History Complete list of historical versions of study NCT00312260 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2008)
change in child's pain-related disability ratings [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2006)
change in child's pain-related disability ratings from baseline to 6 week assessment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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 Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Gabapentin
  • Active Comparator: 2
    Intervention: Drug: Amitriptyline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 6, 2006)
40
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00312260
Other Study ID Numbers  ICMJE 1000008259
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen Brown, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Stephen Brown, MD The Hospital for Sick Children, Toronto Canada
PRS Account The Hospital for Sick Children
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP