Electrogastrogram (EGG) Reproducibility Study: EEG Readings in Normal Subjects and Dyspeptic Patients - NCT00220883-19140 (Clinical Trial 130849)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy130849.aspx
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| City: |
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19140 |
| Conditions: |
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Functional Dyspepsia |
| Purpose: |
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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.
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| Study summary: |
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This is a single-center study. The duration of this trial is estimated to be six months. A
total of Forty (40) subjects will be recruited into this study. It will be two Groups; ten
(10) normal healthy subjects will be recruited by poster advertisement and thirty (30)
patients who either present to the Gastroenterology Department of Temple University Hospital
with varying signs, symptoms or complaints of gastric discomfort, or who are scheduled to
undergo an EGG test by their Gastroenterologist.
Each study subject/patient will have a total of two (2) EGGs with Water load tests performed
for this study. Each EGG exam will be performed approximately one (1) week of each other,
but no more than 4 weeks apart, and will be read in a blinded fashion by three (3) separate
independent readers, in order to see if the readings are consistent with the previous
readings that were obtained, as well as, by the readers themselves (Inter-reader rater
reliability). Each reader will be blinded to the subject status (normal/healthy or
patient) and also to the specific test they are reading (initial exam [Visit 1], or
follow-up exam 1 week after Visit 1 [Visit 2]). All EGG exam results will be coded in order
to keep them blind. |
| Criteria: |
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For normal healthy subjects:
Inclusion Criteria:
1. Male or female patients who are 18 years of age to 72 years of age.
2. Normal healthy subjects with no signs or symptoms of gastrointestinal discomfort.
Exclusion Criteria:
Patients will not be included in this study if they are:
1. < 18 years of age or >72 years of age
2. Subjects with known gastrointestinal or liver cancers, pancreaticobiliary tract
diseases, active peptic ulcer disease or uncontrolled lactose intolerance.
3. Subjects with cardiovascular, pulmonary disorders, or subjects with diabetes
mellitus, a malignancy or who are known to be HIV positive.
4. 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.
5. Subjects who are unable to give informed consent or adequately express their
subjective complaints.
6. Subjects who abuse drugs or alcohol.
7. Female subjects who are pregnant.
For functional dyspepsia patients:
Inclusion Criteria:
1. Male or female patients who are 18 to 72 years of age.
2. Patients who present with varying gastric complaints of discomfort
3. Patients who meet all Rome II criteria for functional dyspepsia (see Rome II criteria
checklist)
Concomitant medications are allowed during the study period. |
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| Study is available at: |
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Temple University School of Medicine
Philadelphia, PA 19140
United States
Primary Contact:
Henry P. Parkman, MD
Email: henry.parkman@temple.edu
Phone: 215-707-3431
Secondary Contact:
Henry P Parkman, MD
Email: henry.parkman@temple.edu
Phone: 1-215-707-7579 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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