Trial Outcomes & Findings for Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age (NCT NCT01206478)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

baseline, 24 weeks

Results posted on

2016-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	9	12
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amitriptyline, Megestrol n=9 Participants 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 n=12 Participants 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 n=21 Participants Total of all reporting groups
Age, Continuous	3.54 age (years) STANDARD_DEVIATION 2.25 • n=5 Participants	3.89 age (years) STANDARD_DEVIATION 1.84 • n=7 Participants	3.73 age (years) STANDARD_DEVIATION 1.99 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	12 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 24 weeks

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.

Outcome measures

Outcome measures
Measure	Amitriptyline, Megestrol n=7 Participants 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 n=7 Participants 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.
% Calories Taken Orally	68.62 change in percent kcal obtained orally Standard Deviation 17.29	76.89 change in percent kcal obtained orally Standard Deviation 15.68

SECONDARY outcome

Timeframe: baseline, 24 weeks

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.

Outcome measures

Outcome measures
Measure	Amitriptyline, Megestrol n=7 Participants 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 n=7 Participants 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.
Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores	-2.5 units on a scale Standard Deviation 19.85	-6.86 units on a scale Standard Deviation 8.65

Adverse Events

Amitriptyline, Megestrol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo, Megestrol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ann M Davis, PI

University of Kansas Medical Center

Phone: 913-588-6300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place