Electrogastrogram (EGG) Reproducibility Study: EEG Readings in Normal Subjects and Dyspeptic Patients

NCT00220883 | Completed

• 1 other identifier: TU4687
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine whether EGG readings obtained from both normal subjects and dyspeptic patients are reproducible from one EGG recording to another on a different day. The secondary objective of this study is to determine whether the EGG readings are analyzed and diagnosed consistently when reviewed and compared by multiple blinded readers when the same tracing is reviewed.

Conditions

Functional Dyspepsia

Keywords

Functional Dyspepsia; Electrogastrography

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients who are 18 years of age to 72 years of age.
• Normal healthy subjects with no signs or symptoms of gastrointestinal discomfort.

You may not qualify if:

• Patients will not be included in this study if they are:
• \< 18 years of age or \>72 years of age
• Subjects with known gastrointestinal or liver cancers, pancreaticobiliary tract diseases, active peptic ulcer disease or uncontrolled lactose intolerance.
• Subjects with cardiovascular, pulmonary disorders, or subjects with diabetes mellitus, a malignancy or who are known to be HIV positive.
• Subjects with a history of gastric, intestinal or colonic resections. Subjects who are at less than a three month status for either: post appendectomy, cholecystectomy, or hysterectomy with or without oophorectomy.
• Subjects who are unable to give informed consent or adequately express their subjective complaints.
• Subjects who abuse drugs or alcohol.
• Female subjects who are pregnant.
• For functional dyspepsia patients:
• Male or female patients who are 18 to 72 years of age.
• Patients who present with varying gastric complaints of discomfort
• Patients who meet all Rome II criteria for functional dyspepsia (see Rome II criteria checklist)
• Concomitant medications are allowed during the study period.

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

Study Officials

• Henry P Parkman, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: September 1, 2006
• Last Updated: August 17, 2020

Record last verified: 2020-08

Locations

US (1)