Study of Medication for Functional Abdominal Pain in Children

Completed · Phase 4 · Has a placebo group

Conditions studied: Functional Gastrointestinal Disorders

In brief

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

Key facts

Study ID

NCT00564525

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

95

Starts

2002-10-01

Expected to finish

2007-06-01

Last updated by the study team

2007-11-28

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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