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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014