Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyspepsia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Gastric Motor Function Measurement

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes