Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Ann Davis, PhD, MPH, ABPP, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01206478
First received: September 20, 2010
Last updated: July 1, 2016
Last verified: May 2016
Results First Received: April 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Chronic Oral Food Refusal
Interventions: Drug: Amitriptyline
Drug: Placebo
Drug: Megestrol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Amitriptyline, Megestrol Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
Placebo, Megestrol

Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.

At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.


Participant Flow:   Overall Study
    Amitriptyline, Megestrol     Placebo, Megestrol  
STARTED     9     12  
COMPLETED     7     7  
NOT COMPLETED     2     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 21 patients were consented to the study.

Reporting Groups
  Description
Amitriptyline, Megestrol Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
Placebo, Megestrol

Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.

At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.

Total Total of all reporting groups

Baseline Measures
    Amitriptyline, Megestrol     Placebo, Megestrol     Total  
Number of Participants  
[units: participants]
  9     12     21  
Age  
[units: age (years)]
Mean (Standard Deviation)
  3.54  (2.25)     3.89  (1.84)     3.73  (1.99)  
Gender  
[units: participants]
     
Female     4     7     11  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
United States     9     12     21  



  Outcome Measures
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1.  Primary:   % Calories Taken Orally   [ Time Frame: baseline, 24 weeks ]

2.  Secondary:   Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores   [ Time Frame: baseline, 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Major weakness was our small sample size, which was directly due to problems with recruitment, which occurred uniformly across sites. The primary reason for refusal was that parents did not want to be randomly assigned to the amitriptyline/placebo.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ann M Davis, PI
Organization: University of Kansas Medical Center
phone: 913-588-6300
e-mail: adavis6@kumc.edu



Responsible Party: Ann Davis, PhD, MPH, ABPP, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01206478     History of Changes
Other Study ID Numbers: 12261
R21HD066629 ( US NIH Grant/Contract Award Number )
Study First Received: September 20, 2010
Results First Received: April 12, 2016
Last Updated: July 1, 2016
Health Authority: United States: Food and Drug Administration