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Trial record 24 of 135 for:    AMITRIPTYLINE

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

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ClinicalTrials.gov Identifier: NCT01206478
Recruitment Status : Completed
First Posted : September 21, 2010
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Oral Food Refusal
Interventions Drug: Amitriptyline
Drug: Placebo
Drug: Megestrol
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amitriptyline, Megestrol Placebo, Megestrol
Hide Arm/Group Description 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: 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.

Period Title: Overall Study
Started 9 12
Completed 7 7
Not Completed 2 5
Arm/Group Title Amitriptyline, Megestrol Placebo, Megestrol Total
Hide Arm/Group Description 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: 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 of all reporting groups
Overall Number of Baseline Participants 9 12 21
Hide Baseline Analysis Population Description
A total of 21 patients were consented to the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Age (years)
Number Analyzed 9 participants 12 participants 21 participants
3.54  (2.25) 3.89  (1.84) 3.73  (1.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 12 participants 21 participants
Female
4
  44.4%
7
  58.3%
11
  52.4%
Male
5
  55.6%
5
  41.7%
10
  47.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 12 participants 21 participants
9 12 21
1.Primary Outcome
Title % Calories Taken Orally
Hide Description Percent Kilocalories (kcal) Obtained Orally. This measure was obtained using the 24 hour food recall, a standardized five-pass method developed by the US Department of Agriculture for use in national dietary surveillance. This measure has been widely used in several large trials and data suggest it is the most valid and reliable method of dietary assessment for children (20). The data were collected at week 0, week 10, and week 24 using standardized probes by highly trained research staff, and parents were presented with paper food models and measuring devices prior to interviews to reference during the recall. Recalls were analyzed with the Nutritional Data System for Research, version 2005; University of Minnesota, Minneapolis, MN.
Time Frame baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amitriptyline, Megestrol Placebo, Megestrol
Hide Arm/Group Description:
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: 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.

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: change in percent kcal obtained orally
68.62  (17.29) 76.89  (15.68)
2.Secondary Outcome
Title Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores
Hide Description Non-communicating Children’s Pain Checklist - Revised (NCCPC-R) used to measure outcome. The NCCPC-R is a 30 item measure intended to assess pain in children who are unable to speak because of cognitive or physical impairments. There are 7 sub-scales including vocal, social, facial, activity, body/limbs, physiological, and eating/sleeping. Each question has a potential score of 0 to 3. Scores are totaled for each sub-scale. Sub-scale scores are then added together for the Total Score. Total Scores can range from 0 to 90. The higher the score, the higher level of pain indicated by the child. This measure was completed by parents at week 0, week 10, and week 24.
Time Frame baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amitriptyline, Megestrol Placebo, Megestrol
Hide Arm/Group Description:
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: 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.

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.5  (19.85) -6.86  (8.65)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amitriptyline, Megestrol Placebo, Megestrol
Hide Arm/Group Description 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: 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.

All-Cause Mortality
Amitriptyline, Megestrol Placebo, Megestrol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Amitriptyline, Megestrol Placebo, Megestrol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amitriptyline, Megestrol Placebo, Megestrol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/12 (0.00%) 
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.
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
Layout table for Results Point of Contact information
Name/Title: Ann M Davis, PI
Organization: University of Kansas Medical Center
Phone: 913-588-6300
EMail: adavis6@kumc.edu
Layout table for additonal information
Responsible Party: Ann Davis, PhD, MPH, ABPP, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01206478     History of Changes
Other Study ID Numbers: 12261
R21HD066629 ( U.S. NIH Grant/Contract )
First Submitted: September 20, 2010
First Posted: September 21, 2010
Results First Submitted: April 12, 2016
Results First Posted: August 15, 2016
Last Update Posted: August 15, 2016