Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 4 Years of Age
Information source: University of Kansas
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Oral Food Refusal
Intervention: Amitriptyline 1 mg/kg (Drug); Placebo (Drug)
Phase: Phase 2
Sponsored by: Ann Davis, PhD, MPH, ABPP
Official(s) and/or principal investigator(s):
Ann Davis, Ph.D., MPH, ABPP, Principal Investigator, Affiliation: University of Kansas
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
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.
Official title: A PHASE II, RANDOMIZED-CONTROLLED, MULTICENTER TRIAL OF AMITRIPTYLINE FOR CHRONIC ORAL FOOD REFUSAL IN CHILDREN 9 MONTHS TO 4 YEARS OF AGE
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: To assess the efficacy of amitriptyline in a 24-week outpatient multi-disciplinary protocol for transitioning children from tube to oral feeding
Secondary outcome: To assess the role of pain in the efficacy of amitriptyline in the 24-week outpatient multidisciplinary protocol.
This research study involves a study drugs called amitriptyline and megestrol. Amitriptyline
might help children who have feeding problems with pain and megestrol is known to increase
appetite. Amitriptyline and megestrol are liquid syrups that are given by feeding tube
Amitriptyline has not been approved by the United States Food and Drug Administration (FDA)
for the treatment of child with feeding problems. Amitriptyline is an investigational drug
that is being studied to find out what the side effects are, and whether or not the product
works for child with feeding problems. Amitriptyline is approved by the FDA for the
treatment of depression.
Megestrol has not been approved by the United States Food and Drug Administration (FDA) for
the treatment of children with feeding problems. Megestrol is an investigational drug that
is being studied to find out what the side effects are, and whether or not the product works
for children with feeding problems. Megestrol has been approved by the FDA for the treatment
of adults. Though megestrol is not FDA approved to treat children with feeding problems, it
is often used for this purpose.
Megestrol and Amitriptyline both affect the nerve cells that carry pain sensations to and
from the brain. Both drugs reduce the intensity of the pain signals going to the part of the
brain that feels pain. Each drug attaches to the nerve cell but at separate spots on the
nerve cell so pain can be better managed.
Minimum age: 9 Months.
Maximum age: 8 Years.
Subjects must meet all of the following inclusion criteria:
1. Males or females 9 months to 8 years 0 months 0 days of age.
2. Able to obtain parental or legal guardian written informed consent from subjects as
applicable by local laws and regulations.
3. Subjects must possess the oral motor skills necessary for eating according to Table 1
in the Appendix.
4. Subjects must possess behavioral skills necessary for mealtime according to Table 2
in the Appendix.
5. Subjects must have a history of chronic oral food refusal (3 months of refusing to
eat more than 5% of their caloric intake orally) and be fed >95% of their caloric
intake through a gastrostomy tube for 3 months or longer.
6. Subjects will be required to have a body mass index for age/gender of 25% or greater
prior to beginning the protocol to ensure that subjects are sufficiently nourished.
Study enrollment will exclude potential subjects with any of the following conditions or
taking any of the following medication:
1. Children on MAO inhibitors or who have thyroid problems will be excluded.
2. Children with diabetes or adrenal insufficiency will be excluded.
3. Children with known heart conduction abnormalities.
4. Children taking tricyclic medications.
Locations and Contacts
University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Ann Davis, Ph.D., MPH, ABPP, Phone: 913-588-6323, Email: firstname.lastname@example.org
Ann Davis, Ph.D., MPH, ABPP, Principal Investigator
Children's Hospital of New Orleans, New Orleans, Louisiana 70118, United States; Recruiting
Paul Hyman, MD, Phone: 504-896-9534, Email: email@example.com
Paul Hyman, MD, Principal Investigator
Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Recruiting
Hayat Mousa, MD, Phone: 614-722-3487, Email: Hayat.Mousa@nationwidechildrens.org
Hayat Mousa, MD, Principal Investigator
Starting date: August 2010
Last updated: October 19, 2012