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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01048840
Other study ID # TAP-PediGERD
Secondary ID 2007-P-000907
Status Completed
Phase
First received
Last updated
Start date September 2004
Est. completion date December 2014

Study information

Verified date November 2020
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this project is to determine the long-term health outcome of children diagnosed with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have compiled a database of more than 200 subjects that completed diagnostic testing for GER in the 1970's and 1980's. Subjects are being contacted initially by mail using a previously approved recruitment letter. Subjects that fail to respond to this recruitment letter are called by phone. In each case, contact information has been abstracted from the Children's Hospital database. Subjects are then given the opportunity to complete a questionnaire either by phone or in hard copy. Subjects receive no compensation for their participation in this study. Subjects will be compared to controls. Controls will complete the same questionnaire as the subjects. Inclusion of potential controls will be determined by a lack of medical history of gastroenterological diseases before the age of 21 and whether the potential control was born within a year of a subject in the study. Controls will receive $25 to participate in the study.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2014
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria for Subjects: - Patients who were evaluated for GERD at the age of 12-17 years, inclusive at Children's Hospital, Boston or Massachusetts General Hospital - Positive for GERD per biopsies or pH probe results Inclusion Criteria for Controls: - No GI diseases prior to age 21 including, but not limited to reflux, inflammatory bowel disease,Hirschsprung's disease - Date of birth is within 1 year of a subject's date of birth

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Children's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

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