NCT01206478

A Phase II, Randomized-Controlled, Multicenter Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age

Completed Phase 2 Results posted Last updated 1 July 2016

What this trial tests

Phase 2 trial testing Amitriptyline in Chronic Oral Food Refusal in 21 participants. Completed in 1 December 2014.

Timeline

1 August 2010

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	Ann Davis, PhD, MPH, ABPP
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	21
Start date	1 August 2010
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	3 locations across United States

Drugs / interventions tested

• Amitriptyline (AMITRIPTYLINE) — full drug profile →
• Placebo
• Megestrol — full drug profile →

Conditions studied

• Chronic Oral Food Refusal — all drugs for Chronic Oral Food Refusal →

Sponsor

Ann Davis, PhD, MPH, ABPP

Who can join

Adults 9 Months to 8, any sex, with Chronic Oral Food Refusal. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• % Calories Taken Orally
  Time frame: 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 collect

Sponsor's own description

Gastrojejunal (G-J) feeding tubes are placed in infants and children who refuse to eat or are unable to eat enough to have normal growth. Although often intended as temporary short-term solutions to medical complications, feeding tubes can become a permanent method for eating.

While tube feeding routinely saves the lives of children who have long term food refusal, continuation of tube feeding can be hard for patients, caregivers, and families. At the current time there are few treatments for helping children move from tube to oral feeding. Some patients may be treated with the help of inpatient programs such as a combination of medical and behavioral techniques to train children to eat orally. These programs typically require hospital stays of 2-4 months.

By doing the current study the investigators hope to learn if the investigational drug amitriptyline is helpful in moving children from tube to oral feeding, and to look at whether or not the treatment of pain helps with this transition.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Randomized Controlled Trial of an Outpatient Protocol for Transitioning Children from Tube to Oral Feeding: No Need for Amitriptyline.
   Davis AM, Dean K, Mousa H, Edwards S, et al · · 2016 · cited 20× · PMID 26947568 · DOI 10.1016/j.jpeds.2016.02.013
2. Family mealtime behaviors in children who are tube fed and preparing to transition to oral eating: A comparison to other pediatric populations.
   Garcia AM, Beauchamp MT, Patton SR, Edwards S, et al · · 2022 · cited 4× · PMID 33339464 · DOI 10.1177/1359105320982034