Gastric Motor Function Measurement in Dyspepsia and Normal Subjects
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00296582
First received: February 24, 2006
Last updated: May 20, 2011
Last verified: May 2011
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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
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 May 16, 2013