Study of Medication for Functional Abdominal Pain in Children

NCT00564525 | Completed Phase 4 DMC

• 1 other identifier: 2005-12430
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Gastrointestinal Disorders

Keywords

children; abdominal pain; amitriptyline

Outcome Measures

Primary Outcomes (1)

• Patient report on wether amitriptyline therapy resulted in adequate relief of symptoms

  5 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Drug: Placebo

2

EXPERIMENTAL

Amitriptyline given

Drug: Amitriptyline

Interventions

Amitriptyline DRUG

Medication taken for 4 weeks

Also known as: Other names include: Elavil, Trepiline and Laroxyl.

2

Placebo DRUG

Medication taken for 4 weeks

1

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• American College of Gastroenterology: collaborator

Study Sites (1)

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Abdominal Pain

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Miguel Saps, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 28, 2007
• Study Start: October 1, 2002
• Study Completion: June 1, 2007
• Last Updated: November 28, 2007

Record last verified: 2007-11

Locations

US (1)