A double-blind, randomised, placebo controlled crossover study on the effects of 100mg, three times daily, Z-338 on the symptomatic response to a nutrient challenge and gasteric nutrient distribution and emptying in subjects with and without functional dyspepsia.

Phase 2

Completed

• Conditions: Functional dyspepsia; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12605000794606
• Lead Sponsor: Zeria Pharmaceutical Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the improvement of meal related symptoms in healthy controls and subjects with functional dyspepsia during treatment with Z-338.[subject completes assessments 60 days after commencing treatment.]

Secondary Outcome Measures

Name	Time	Method
The influence of the treatment on the regional nutrient distribution (%) of ingested test meal in the proximal and distal stomach.[subject completes assessments 60 days after commencing treatment.];Changes of gastric emptying and the link of regional gastric nutrient distribution/gastric emptying and improvement of meal related symptoms referred to the upper stomach occurs (i.e. pain, nausea, fullness and discomfort) will be analyzed.[subject completes assessments 60 days after commencing treatment.]