Clinical trial: Preliminarily Evaluate the Efficacy of Domperidone in Adult Chinese Participants With Functional Dyspepsia (NCT03617016)

Eligibility criteria:
Inclusion Criteria:

          -  Must meet the diagnostic criteria for functional dyspepsia (Postprandial Distress
             Syndrome [PDS] and/or Epigastric Pain Syndrome [EPS]) according to Rome IV diagnostic
             criteria for functional gastrointestinal disorders before and through screening

          -  Must have had an upper endoscopy that shows no evidence of structural change that is
             likely to explain the dyspepsia symptoms. If the participant has had the upper
             endoscopy performed within 3 months before screening, no re-test is needed

          -  Must have an abdominal ultrasonography that shows no evidence of organic disease that
             is likely to explain the dyspepsia symptoms. If the participant has the abdominal
             ultrasonography performed within 3 months before screening, no re-test is needed

          -  A woman of childbearing potential must have a negative serum (beta human chorionic
             gonadotropin [beta-hCG]) pregnancy test at Screening

          -  A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
             reproduction during the study and for 30 days after receiving the last dose of study
             drug

          -  Otherwise healthy on the basis of physical examination, medical history, vital signs,
             and 12-lead electrocardiogram (ECG) performed at screening. If there are
             abnormalities, they must be consistent with the underlying illness in the study
             population. This determination must be recorded in the participant's source documents
             and signed by the investigator. Specifically, for vital signs, the participant must
             have blood pressure (after participant has been supine for 10 minutes) between 90 and
             140 millimeter of mercury (mmHg) systolic (inclusive) and between 60 and 90 mmHg
             diastolic (inclusive)

        Exclusion Criteria:

          -  Has a history of or current clinically significant medical illness including (but not
             limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
             coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid
             abnormalities, significant pulmonary disease (including bronchospastic respiratory
             disease), diabetes mellitus, renal or hepatic insufficiency, thyroid disease,
             neurologic or psychiatric disease, or any other illness that the investigator
             considers should exclude the participant or that could interfere with the
             interpretation of the study results

          -  Has history of risk factors for Torsade de Pointes or family history of short QT
             syndrome, long QT syndrome, sudden unexplained death at a young age (less than or
             equal to [<=] 40 years); or a history of second- or third-degree heart block

          -  Has clinically significant electrolyte disorders or conditions that result in
             electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating
             disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in
             acute settings

          -  Has a history of esophageal, gastric, or duodenal surgery, including endoscopic
             surgery

          -  Has any condition in which stimulation of gastric motility might be dangerous, for
             example (e.g.), in the presence of gastrointestinal (GI) hemorrhage, mechanical
             obstruction, or perforation

          -  Has used any of the following medications 7 days before screening: proton pump
             inhibitors, antacids, anti-secretory agents, histamine2 receptor antagonists, gastric
             mucosa protective agents, digestive enzymes, prokinetic agents (including macrolide
             antibiotics), and other drugs that affect gastrointestinal function, QT-prolonging
             drugs, cytochrome P450 3A4 inhibitors, monoamine oxidase inhibitors (MAOIs),
             nonsteroidal anti-inflammatory agents, aspirin (including low-dose aspirin),
             anticholinergics, antidepressants, or diuretics
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? 0