Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age
Condition: Chronic Oral Food Refusal
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Amitriptyline; Placebo; Megestrol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Amitriptyline 1 mg/kg once daily at bedtime.; 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 will receive a prescription for the appetite stimulant megestrol. The dose each child will receive depends on their age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
Intervention MeSH terms: Megestrol; Amitriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment