Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Oral Food Refusal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Amitriptyline plus Megestrol

Amitriptyline once daily at bedtime plus megestrol starting at visit 2

Group Type EXPERIMENTAL

Amitriptyline

Intervention Type DRUG

Amitriptyline 1 mg/kg once daily at bedtime.

Megestrol

Intervention Type DRUG

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.

Placebo plus Megestrol

Matching placebo once daily at bedtime plus megestrol starting at visit 2

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (looks like study drug but has no active ingredients) once daily at bedtime.

Megestrol

Intervention Type DRUG

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.

Interventions

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Amitriptyline

Amitriptyline 1 mg/kg once daily at bedtime.

Intervention Type DRUG

Placebo

Placebo (looks like study drug but has no active ingredients) once daily at bedtime.

Intervention Type DRUG

Megestrol

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 Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

9 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes