Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00296582
First received: February 24, 2006
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Dyspepsia
Behavioral: Gastric Motor Function Measurement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Simultaneous Gastric Motor Function Measurement in Dyspepsia And Normal Subjects Ingesting a Solid-Liquid Meal

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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

Enrollment: 30
Study Start Date: January 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296582

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: H. Jae Kim, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Hack Jae Kim, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00296582     History of Changes
Other Study ID Numbers: 65-06
Study First Received: February 24, 2006
Last Updated: May 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014