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Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

Primary Purpose

Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastric Motor Function Measurement
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dyspepsia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: Dyspeptic Subjects: Recurrent episodes of upper abdominal pain or discomfort including early satiety, fullness, bloating, or nausea for at least 3 months in the prior year. A baseline impaired satiety test (maximum tolerated volume 25% of normal or 1000cc). No evidence on esophagogastroduodenoscopy of erosions, peptic ulcer, pyloric obstruction, esophagitis or malignancy in the prior 3 years. All Subjects: No history suggestive of small bowel obstruction. Exclusion criteria No structural or metabolic diseases/conditions that affect the gastrointestinal system. Unable to stop medications 48 hours prior to the study that: Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants. Analgesic drugs including opiates, NSAID, COX 2 inhibitors Systemic antifungal drugs Carbamazepine, glucocorticoids, phenobarbital, phenytoin, rifampin, but also grapefruit juice. Benzodiazepines NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible. Female subjects who are pregnant or breast feeding. Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study. Subjects who have participated in another clinical study within the past 30 days. Previous gastric or intestinal surgery (except appendectomy , cholecystectomy or hysterectomy).

Sites / Locations

  • Mayo Clinic

Outcomes

Primary Outcome Measures

Fasting and postprandial gastric volumes (Gastric accommodation)

Secondary Outcome Measures

T1/2 of gastric emptying of solid
Maximum tolerated volume
Individual postprandial symptom scores

Full Information

First Posted
February 24, 2006
Last Updated
May 20, 2011
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00296582
Brief Title
Gastric Motor Function Measurement in Dyspepsia and Normal Subjects
Official Title
Simultaneous Gastric Motor Function Measurement in Dyspepsia And Normal Subjects Ingesting a Solid-Liquid Meal
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being done to measure the functions of the stomach after eating a meal and to develop a new method that will simultaneously measure both gastric emptying and the relaxation of the stomach after a meal using nuclear medicine testing. This would make the testing more convenient for patients and will also offer better understanding of these two gastric functions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Gastric Motor Function Measurement
Primary Outcome Measure Information:
Title
Fasting and postprandial gastric volumes (Gastric accommodation)
Secondary Outcome Measure Information:
Title
T1/2 of gastric emptying of solid
Title
Maximum tolerated volume
Title
Individual postprandial symptom scores

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Dyspeptic Subjects: Recurrent episodes of upper abdominal pain or discomfort including early satiety, fullness, bloating, or nausea for at least 3 months in the prior year. A baseline impaired satiety test (maximum tolerated volume 25% of normal or 1000cc). No evidence on esophagogastroduodenoscopy of erosions, peptic ulcer, pyloric obstruction, esophagitis or malignancy in the prior 3 years. All Subjects: No history suggestive of small bowel obstruction. Exclusion criteria No structural or metabolic diseases/conditions that affect the gastrointestinal system. Unable to stop medications 48 hours prior to the study that: Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants. Analgesic drugs including opiates, NSAID, COX 2 inhibitors Systemic antifungal drugs Carbamazepine, glucocorticoids, phenobarbital, phenytoin, rifampin, but also grapefruit juice. Benzodiazepines NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible. Female subjects who are pregnant or breast feeding. Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study. Subjects who have participated in another clinical study within the past 30 days. Previous gastric or intestinal surgery (except appendectomy , cholecystectomy or hysterectomy).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Jae Kim, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

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Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

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