Gastric Motor Function Measurement in Dyspepsia and Normal Subjects - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 24, 2006

Last Updated Date

December 17, 2007

Start Date ^†

January 2006

Current Primary Outcome Measures ^†

Fasting and postprandial gastric volumes (Gastric accommodation)

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00296582 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

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

Descriptive Information

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

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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^†

Dyspepsia

Intervention ^†

Behavioral: Gastric Motor Function Measurement

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

June 2007

Primary Completion Date

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).

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00296582

Responsible Party

Hack Jae Kim, M.D., Mayo Clinic

Secondary IDs ^††

Study Sponsor ^†

Mayo Clinic

Collaborators ^††

Investigators ^†

Principal Investigator:

H. Jae Kim, M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.