Study of Medication for Functional Abdominal Pain in Children

This study has been completed.
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00564525
First received: November 27, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

The purpose of this study is to determine where amitriptyline is effective in the treatment of functional abdominal pain in children.


Condition Intervention Phase
Functional Gastrointestinal Disorders
Drug: Amitriptyline
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Amitriptyline in Children With Abdominal Pain of Non-Organic Origin

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Patient report on wether amitriptyline therapy resulted in adequate relief of symptoms [ Time Frame: 5 weeks ]

Enrollment: 95
Study Start Date: October 2002
Study Completion Date: June 2007
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Medication taken for 4 weeks
Experimental: 2
Amitriptyline given
Drug: Amitriptyline
Medication taken for 4 weeks
Other Name: Other names include: Elavil, Trepiline and Laroxyl.

Detailed Description:

Recurrent gastro-intestinal complaints constitute one of the most common reasons for medical consultation among daycare and school children. Studies suggest an association between childhood functional abdominal pain and psychiatric disorders. Although most children with mild symptoms are mostly managed by reassurance and simple measures, a large range of interventions such as dietary changes, use of antidepressant and medications are being widely used with little evidence to suggest their effectiveness. In view of the high prevalence of this disorder and the lack of pediatric scientific evidence on extensively used drug therapies there is critical need to develop trials of all suggested pharmacologic interventions in children with functional pain disorders. This study has the potential to fill a critical void in pediatric gastroenterology.

The main objective of this study is to evaluate the impact of the medication (amitriptyline) on symptoms of patients with abdominal pain of non-organic origin.

Our hypotheses are that amitriptyline results in adequate relief of symptoms in children with functional abdominal pain and that is more effective than placebo in controlling pain.

This is a randomized, double masked placebo controlled study, using standard current measures and diagnostic criteria to address the question whether the treatment with amitriptyline is efficacious, and that leads to an improvement in severity of the symptoms for which the patient sought medical attention.

The study is conducted on a group of children (eight to eighteen years) suffering from functional abdominal pain. The study population is randomly assigned (by chance) into 2 groups (half of the patients receive drug and half of patients receive a non-acting drug-placebo). Each individual will randomly receive the medication or placebo at night time for 4 weeks. In order to qualify for the study the patients have to complete one week on baseline questionnaires to assess their symptoms and have to be diagnosed with a condition associated with functional abdominal pain by the investigators. The patient will complete initial questionnaires and end of the study questionnaires as well as daily questionnaires to assess the symptoms. At the end of the study both groups will be compared to establish differences.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 8 to 17 years
  • Diagnosis of functional abdominal pain or irritable bowel syndrome made by a pediatric gastroenterologist according to Rome II criteria
  • Mean daily intensity of pain of 25 mm in the week prior to the initiation of the study, based on the Word-Graphic Rating Scale continuous score
  • Following evaluation in the six months prior to the study: normal EKG and laboratory tests including complete blood count, erythrocyte sedimentation rate, albumin, serum amylase, lipase, liver enzymes, urine analysis, stool examination for occult blood and ova and parasites. Urinary culture will be obtained if the symptoms or urinalysis suggest the possibility of a urinary infection,
  • Normal lactose breath test or history of lack of resolution of symptoms on a lactose-free diet
  • Consenting parents
  • Patient assent

Exclusion Criteria:

  • Inclusion criteria not met
  • Evidence of organic gastrointestinal disease, hepatic disorders, urinary or cardiac disease, seizures, blood dyscrasias, glaucoma
  • History of allergic reaction to amitriptyline
  • Patients receiving barbiturates, cimetidine, neuroleptics, monoamine oxidase inhibitors, sympathomimetic agents or quinidine
  • Children below the 5th percentile for weight or height
  • Hemoccult positive stools
  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: NCT00564525

Locations
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
American College of Gastroenterology
Investigators
Principal Investigator: Miguel Saps, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00564525     History of Changes
Other Study ID Numbers: 2005-12430
Study First Received: November 27, 2007
Last Updated: November 27, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
children
abdominal pain
amitriptyline

Additional relevant MeSH terms:
Abdominal Pain
Digestive System Diseases
Gastrointestinal Diseases
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Amitriptyline
Amitriptyline, perphenazine drug combination
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

ClinicalTrials.gov processed this record on September 16, 2014