Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 4 Years of Age
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.
Chronic Oral Food Refusal
Drug: Amitriptyline 1 mg/kg
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- To assess the efficacy of amitriptyline in a 24-week outpatient multi-disciplinary protocol for transitioning children from tube to oral feeding [ Time Frame: weekly for 24 weeks ] [ Designated as safety issue: No ]
- To assess the role of pain in the efficacy of amitriptyline in the 24-week outpatient multidisciplinary protocol. [ Time Frame: weekly for 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Experimental: Amitriptyline, Megestrol||
Drug: 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.
|Active Comparator: Placebo, Megestrol||
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.
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.
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Ann Davis, Ph.D., MPH, ABPP 913-588-6323 firstname.lastname@example.org|
|Principal Investigator: Ann Davis, Ph.D., MPH, ABPP|
|United States, Louisiana|
|Children's Hospital of New Orleans||Recruiting|
|New Orleans, Louisiana, United States, 70118|
|Contact: Paul Hyman, MD 504-896-9534 email@example.com|
|Principal Investigator: Paul Hyman, MD|
|United States, Ohio|
|Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43205|
|Contact: Hayat Mousa, MD 614-722-3487 Hayat.Mousa@nationwidechildrens.org|
|Principal Investigator: Hayat Mousa, MD|
|Principal Investigator:||Ann Davis, Ph.D., MPH, ABPP||University of Kansas|