Gastric Motor Function Measurement in Dyspepsia and Normal Subjects

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296582
• Other study ID #: 65-06
• Status: Completed
• Phase: N/A
• First received: February 24, 2006
• Last updated: May 20, 2011
• Start date: January 2006
• Est. completion date: June 2007

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Behavioral:
• Gastric Motor Function Measurement

Locations

Country	Name	City	State
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting and postprandial gastric volumes (Gastric accommodation)
Secondary	T1/2 of gastric emptying of solid
Secondary	Maximum tolerated volume
Secondary	Individual postprandial symptom scores