Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01048840
First received: January 13, 2010
Last updated: April 22, 2010
Last verified: April 2010

January 13, 2010
April 22, 2010
September 2004
June 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01048840 on ClinicalTrials.gov Archive Site
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Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
The Natural History of Children With Gastroesophageal Reflux Disease (Ages 15 Months to 11 Years)

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.

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Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample

The subjects will be selected from a database of patients seen at Children's Hospital, Boston or Massachusetts General Hospital between 1977 and 1990 who had biopsies or pH probe for symptoms of GERD.

Gastroesophageal Reflux
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  • Subject with History of GERD
    Children and adolescents ages 12-17 years, inclusive, seen at Children's Hospital, Boston or Massachusetts General Hospital between 1977 and 1990 for symptoms of GERD and also had biopsies and / or a pH probe that was positive for GERD.
  • Controls with out GERD
    Individuals that do not have a history of GERD or other GI problems prior to age 21 and whose date of birth are with in a year of a subjects
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01048840
TAP-PediGERD, 2007-P-000907
No
Harland Winter, MD
Massachusetts General Hospital
TAP Pharmaceutical Products Inc.
Principal Investigator: Harland S Winter, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP