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CompletedNCT00296582Updated May 23, 2011

Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

An interventional study of Gastric Motor Function Measurement in Dyspepsia, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-23.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dyspepsia

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03

In context

Dyspepsia

363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.

This study's enrollment of 30 is below the median of 87 across 297 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Interventions

  • BehavioralGastric Motor Function Measurement
06

What researchers measure

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

07

Study locations

1 site
  • Mayo Clinic
    Scottsdale, Arizona 85259, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00296582
Lead sponsor
Mayo Clinic
First posted
Feb 27, 2006
Start date
Jan 2006
Primary completion
Jun 2007
Completion
Jun 2007
Last update
May 23, 2011

Study contacts

H. Jae Kim, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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