Status:
COMPLETED
Gastric Motor Function Measurement in Dyspepsia and Normal Subjects
Lead Sponsor:
Mayo Clinic
Conditions:
Dyspepsia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 stomac...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00296582
Start Date
January 1 2006
End Date
June 1 2007
Last Update
May 23 2011
Active Locations (1)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259