Functional Dyspepsia Treatment Trial

Inclusion Criteria:

• Normal esophagogastroduodenoscopy (EGD) (no esophagitis, Barrett's esophagus, cancer,erosions, or ulcer disease) within the past 5 years

• Diagnosis of functional dyspepsia

• Patients may have failed to adequately respond to antisecretory therapy in the pastfor functional dyspepsia to be suitable; a good response to antisecretory therapy,which remains first line therapy, suggests underlying gastroesophageal reflux disease (GERD).

Exclusion Criteria:

• Any documented history of endoscopic esophagitis, or predominant heartburn or acidregurgitation, or these symptoms two or more times per week in the prior year, toexclude GERD.

• Those who have had an adequate response to antisecretory therapy according to thephysician interview, to exclude patients with disease easy to control with first linetherapy or misdiagnosed GERD.

• Any documented peptic ulcer disease.

• Regular use of non-steroidal anti-inflammatory drugs (except long term low doseaspirin ≤ 325 mg / day)

• Subjects undergoing psychiatric treatment, having a current history of drug or alcoholabuse, or currently taking psychotropic medication for depression or psychosis, oreating 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 thyroiddisease, vasculitis, lactose intolerance explaining symptoms)

• Subjects whose literacy skills are insufficient to complete self reportquestionnaires.

• 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 theHospital Anxiety Depression Scale will be excluded. These patients will be encouragedto get follow up for depression.

• All eligible patients over age 50 will have an EKG before randomization. Those foundto have significant arrhythmias, conduction defects or a previous myocardialinfarction 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.