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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ann Davis, PhD, MPH, ABPP, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01206478
First received: September 20, 2010
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Chronic Oral Food Refusal
Drug: Amitriptyline 1 mg/kg
Drug: Placebo
Phase 2

Study Type: Interventional
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 8 YEARS OF AGE

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: August 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Drug: Placebo

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.


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

Ages Eligible for Study:   9 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206478

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Ann Davis, PhD, MPH, ABPP
Investigators
Principal Investigator: Ann Davis, Ph.D., MPH, ABPP University of Kansas
  More Information

No publications provided

Responsible Party: Ann Davis, PhD, MPH, ABPP, Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01206478     History of Changes
Other Study ID Numbers: 12261
Study First Received: September 20, 2010
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Amitriptyline
Amitriptyline, perphenazine drug combination
Megestrol
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 28, 2014