Skip to main content
OpenTrials
Completed

NCT Number: NCT00296582

Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Gastric Motor Function Measurement

Behavioral

Primary outcomes

  1. Fasting and postprandial gastric volumes (Gastric accommodation)

Secondary outcomes

  1. T1/2 of gastric emptying of solid

  2. Maximum tolerated volume

  3. Individual postprandial symptom scores

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Simultaneous Gastric Motor Function Measurement in Dyspepsia And Normal Subjects Ingesting a Solid-Liquid Meal

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 27, 2006
Registry last updated
May 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.