Status:
TERMINATED
Tricyclic Antidepressants (TCAs) on Gastric Emptying
Lead Sponsor:
Temple University
Conditions:
Dyspepsia
Eligibility:
All Genders
18-72 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effects of two tricyclic antidepressant agents (TCAs), amitriptyline and desipramine, on gastric emptying and gastric accommodation using a newly develope...
Detailed Description
The normal control subjects will be randomized to receive either amitriptyline or desipramine as the tricyclic antidepressant agent, with 30 subjects per group. Subjects will undergo two outpatient ga...
Eligibility Criteria
Inclusion
- Sixty normal subjects, males and females within the ages of 18 to 65 years, will be studied. Normal control subjects will be recruited for voluntary participation through poster advertisements. A normal subject is defined as a person with no gastrointestinal (GI) symptoms; no prior history of peptic ulcer disease or irritable bowel disease; no previous history of a GI motility disorder (including, but not limited to, achalasia, gastroparesis); on no medications for GI disorders; no history of prior surgery on the GI tract (esophagus, stomach, large or small intestine); and a normal physical examination.
Exclusion
- History of a motility disorder (including, but not limited to, achalasia, gastroparesis)
- History of peptic ulcer disease
- Symptoms referable to gastric dysmotility (nausea, vomiting, early satiety, heartburn, postprandial abdominal distension)
- Use of medications that may affect GI motor function (beta adrenergic receptor blockers, calcium channel blockers, histamine type 2 receptor antagonists, proton pump inhibitors, prokinetic agents, antidepressants, and the use of narcotic analgesics)
- Regular use of nonsteroidal anti-inflammatory medications
- Use of monoamine oxidase inhibitors
- Pregnancy or breast feeding
- Prior gastrointestinal surgery (except appendectomy)
- Contraindications to amitriptyline or desipramine, which will be exclusion criteria to the study, include hypersensitivity or allergy to any tricyclic drug, concomitant therapy with a monoamine oxidase inhibitor, recent myocardial infarction, myelography within previous 48 hours, or lactation. In addition, history of prostate problems, history of urinary retention, known glaucoma, history of seizures, or thyroid or liver dysfunction are exclusionary criteria to the use of TCAs and to entry into this study.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00220844
Start Date
September 1 2005
End Date
June 1 2014
Last Update
March 5 2021
Active Locations (1)
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1
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140