Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Ann Davis, PhD, MPH, ABPP
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Treatments:
Amitriptyline Amitriptyline, perphenazine drug combination Megestrol Megestrol Acetate