Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 4 Years of Age
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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 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 ]
| Estimated Enrollment: | 72 |
| 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) |
| 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 |
Inclusion Criteria
Subjects must meet all of the following inclusion criteria:
- Males or females 9 months to 8 years 0 months 0 days of age.
- Able to obtain parental or legal guardian written informed consent from subjects as applicable by local laws and regulations.
- Subjects must possess the oral motor skills necessary for eating according to Table 1 in the Appendix.
- Subjects must possess behavioral skills necessary for mealtime according to Table 2 in the Appendix.
- 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.
- 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:
- Children on MAO inhibitors or who have thyroid problems will be excluded.
- Children with diabetes or adrenal insufficiency will be excluded.
- Children with known heart conduction abnormalities.
- Children taking tricyclic medications.
Contacts and Locations| 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 adavis6@kumc.edu | |
| 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 phyman@lsuhsc.edu | |
| 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 |
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: | April 24, 2013 |
| 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 June 17, 2013