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Trial registered on ANZCTR


Registration number
ACTRN12605000794606
Ethics application status
Approved
Date submitted
15/12/2005
Date registered
16/12/2005
Date last updated
1/10/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional dyspepsia 953 0
Condition category
Condition code
Oral and Gastrointestinal 1022 1022 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3491 0
Treatment: Drugs
Comparator / control treatment
Placebo will be provided to participants instead of the study drug Z-338.
Control group
Placebo

Outcomes
Primary outcome [1] 1371 0
To assess the improvement of meal related symptoms in healthy controls and subjects with functional dyspepsia during treatment with Z-338.
Timepoint [1] 1371 0
subject completes assessments 60 days after commencing treatment.
Secondary outcome [1] 2428 0
The influence of the treatment on the regional nutrient distribution (%) of ingested test meal in the proximal and distal stomach.
Timepoint [1] 2428 0
subject completes assessments 60 days after commencing treatment.
Secondary outcome [2] 2429 0
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.
Timepoint [2] 2429 0
subject completes assessments 60 days after commencing treatment.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study is a randomised crossover design in which both groups take placebo and active drug at different intervals of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Healthy volunteers will be assigned to a unique sequence of numbers, diagnosed functional dyspepsia patients will be assigned a seperate unique number sequencing system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1124 0
Commercial sector/Industry
Name [1] 1124 0
Zeria Pharmaceutial Co., Ltd
Address [1] 1124 0
10-11 Nihonbashi Kobuna-Cho, Chuo-Ku 103-8351, Tokyo
Country [1] 1124 0
Japan
Primary sponsor type
Commercial sector/Industry
Name
Zeria Pharmaceutical Co., Ltd
Address
10-11 Nihonbashi Kobuna-Cho, Chuo-Ku 103-8351, Tokyo
Country
Japan
Secondary sponsor category [1] 982 0
Commercial sector/Industry
Name [1] 982 0
Kendle
Address [1] 982 0
1200 Carew Tower, 441 Vine Street, Cincinnati, Ohio 45202
Country [1] 982 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2442 0
Royal Adelaide Hospital
Ethics committee address [1] 2442 0
Ethics committee country [1] 2442 0
Australia
Date submitted for ethics approval [1] 2442 0
Approval date [1] 2442 0
Ethics approval number [1] 2442 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36100 0
Address 36100 0
Country 36100 0
Phone 36100 0
Fax 36100 0
Email 36100 0
Contact person for public queries
Name 9995 0
Lee-Anne Faraguna (study co-ordinator)
Address 9995 0
Gasteroenterology, Hepatology and General Medicine Department
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 9995 0
Australia
Phone 9995 0
+61 8 82225827
Fax 9995 0
Email 9995 0
LFaragun@mail.rah.sa.gov.au
Contact person for scientific queries
Name 923 0
Professor Gerald Holtman
Address 923 0
Gasteroenterology, Hepatology and General Medicine Department
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 923 0
Australia
Phone 923 0
+61 8 82225207
Fax 923 0
Email 923 0
gholtman@mail.rah.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary