Functional Dyspepsia Treatment Trial

Exclusion Criteria

• •Any documented history of endoscopic esophagitis, or predominant heartburn or acid regurgitation, or these symptoms two or more times per week in the prior year, to exclude GERD.
• •Those who have had an adequate response to antisecretory therapy according to the physician interview, to exclude patients with disease easy to control with first line therapy or misdiagnosed GERD.
• •Any documented peptic ulcer disease.
• •Regular use of non-steroidal anti-inflammatory drugs (except long term low dose aspirin ≤ 325 mg / day)
• •Subjects undergoing psychiatric treatment, having a current history of drug or alcohol abuse, or currently taking psychotropic medication for depression or psychosis, or eating disorders
• •A history of abdominal surgery except appendectomy, cholecystectomy or hysterectomy, tubal ligations, bladder slings, and vasectomies
• •Subjects with concurrent major physical illness (including cardiac or liver disease, diabetes, inflammatory bowel disease, glaucoma, urinary retention, active thyroid disease, vasculitis, lactose intolerance explaining symptoms)
• •Subjects whose literacy skills are insufficient to complete self report questionnaires.
• •Pregnancy, or refusal to apply adequate contraceptive measures during the trial
• •Subjects currently on antidepressant therapy will be excluded.
• •Patients who score 11 or greater on the 7 questions related to depression of the Hospital Anxiety Depression Scale will be excluded. These patients will be encouraged to get follow up for depression.
• •All eligible patients over age 50 will have an EKG before randomization. Those found to have significant arrhythmias, conduction defects or a previous myocardial infarction on EKG will be excluded. Anyone with QT prolongation will be excluded.
• •The following concomitant medications will be prohibited during the trial:
• •Systemically acting cholinergics and anticholinergics (atropine, didinium bromide, propantheline)
• •Prokinetics (e.g., metoclopramide, tegaserod)
• •Macrolide antibiotics (e.g., erythromycin, azithromycin)
• •Aspirin (\> 325 mg/day)
• •Spasmolytics (e.g., dicyclomine)
• •Antidepressants other than study medications
• •Serotonin enhancing drugs: monamine oxidase inhibitors, anticonvulsants, dextromethorphan.
• •Participants will be instructed to avoid grapefruit/grapefruit juice during the trial.