Clinical trial NCT01206478: Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age
Official title: A Phase II, Randomized-Controlled, Multicenter Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Oral Food Refusal
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-09-21
Enrollment: 21
Sex: ALL
Minimum age (years): 9
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 daily.

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.

Eligibility criteria: Inclusion Criteria

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.

Exclusion Criteria

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.

Primary outcomes:
measure: % Calories Taken Orally
timeFrame: baseline, 24 weeks
Secondary outcomes:
measure: Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores
timeFrame: baseline, 24 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Children's Hospital of New Orleans
state: Louisiana
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: University of Kansas Medical Center
name: Ann Davis, Ph.D., MPH, ABPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia AM, Beauchamp MT, Patton SR, Edwards S, Dreyer Gillette ML, Davis AM. Family mealtime behaviors in children who are tube fed and preparing to transition to oral eating: A comparison to other pediatric populations. J Health Psychol. 2022 Mar;27(4):1014-1020. doi: 10.1177/1359105320982034. Epub 2020 Dec 18.
citation: Davis AM, Dean K, Mousa H, Edwards S, Cocjin J, Almadhoun O, He J, Bruce A, Hyman PE. A Randomized Controlled Trial of an Outpatient Protocol for Transitioning Children from Tube to Oral Feeding: No Need for Amitriptyline. J Pediatr. 2016 May;172:136-141.e2. doi: 10.1016/j.jpeds.2016.02.013. Epub 2016 Mar 3.