None listed
Conditions
Brief summary
Zeria Pharmaceutical Co. Ltd is studying an investigational drug called Z-338. This drug is not available for sale in the United States or Australia. Z-338 is being studied as a possible treatment for functional dyspepsia (FD). FD is a disease that causes various abdominal symptoms such as fullness, stomach pain, nausea, early satiety and bloating.
Interventions
Recent studies have demonstrated that various pharmacologic treatments including proton pump inhibitors (PPI) and prokinetics and psychological treatments improve the symptoms in subjects with functional dyspepsia. The mode of action of gastroprokinetic drugs is via various receptor mechanisms, which include action at motlin receptors, serotonin receptors, dopamine receptors and/or acetylcholinesterase.The effects of treatment with the study drug Z-338 yielded significant improvement of symptoms
Recent studies have demonstrated that various pharmacologic treatments including proton pump inhibitors (PPI) and prokinetics and psychological treatments improve the symptoms in subjects with functional dyspepsia. The mode of action of gastroprokinetic drugs is via various receptor mechanisms, which include action at motlin receptors, serotonin receptors, dopamine receptors and/or acetylcholinesterase.The effects of treatment with the study drug Z-338 yielded significant improvement of symptoms in functional dyspepsia in a well controlled study in Japan. The aim of this study, therefore, is to assess in healthy controls and subjects with functional dyspepsia the effects of the study drug Z-338 on the type and severity of symptoms during standardized nutrient challenge, the gastric nutrient distribution and gastric emptying of a standardized nutrient challenge and the association of the prior mentioned points with manifestations of symptoms and symptom pattern.
Sponsors
Zeria Pharmaceutical Co., Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(Subjects with no history of functional dyspepsia):1) Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality (e.g. no need for further clinical testing)Inclusion criteria (Subjects with functional dyspepsia):1) Diagnosis of functional dyspepsia according to Rome II criteria and three or more moderate symptoms of Gastrointestinal Symptom Score.
Exclusion criteria
(All subjects):1) previous abdominal or gynaecological surgery (except appendectomies, vaginal hysterectomy, diagnostic laparscope and other as determined by Investigator).2) previous gastrointestinal cancer, previous malignancy, except non-metastatic basak or squamous cell carcinoma cancer within the last five years.3) known current peptic ulcer disease4) predominant gastro-esophageal reflux symptoms or Irritable Bowel Syndrome.5) pregnancy or breast feeding6) Treatment with antibiotics 8 weeks prior7) Taking acid suppressing medications (proton pump inhibitors, histamine 2 receptor antagonist, antacids), prokinetics (e.g. Cisapride, Maroon) for 2 weeks.8) Diabetes on continuous medical therapy9) clinically relevant cardiovascular disease (as assessed by the Investigator)10) Any clinically relevant uncontrolled medical condition (as assessed by the investigator)11) No other clinical trials within the last 30 days12) Subject has not been a volunteer in any other research projects which have involved radioactivity exposure in the last twelve months.13) Subject testing positive for Helicobacter pylori.
Outcome results
None listed