Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00298194




Registration number
NCT00298194
Ethics application status
Date submitted
28/02/2006
Date registered
1/03/2006
Date last updated
14/01/2009

Titles & IDs
Public title
The Effects of Z-338 in Subjects With and Without Functional Dyspepsia
Scientific title
The Effects of Z-338 on the Symptomatic Response to a Nutrient Challenge and Gastric Nutrient Distribution and Emptying in Subjects With and Without Functional Dyspepsia
Secondary ID [1] 0 0
99010205E
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyspepsia 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 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
Treatment: Drugs - Z-338

Treatment: Drugs: Z-338
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
1. Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII
criteria and three or more moderate symptoms of Gastrointestinal Score

2. Subjects with no history of functional dyspepsia Clinical assessment, physical
examination and laboratory testing without evidence for relevant abnormality.

Other protocol-defined inclusion/exclusion criteria may apply.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zeria Pharmaceutical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To assess in subjects with and without functional dyspepsia the effects of Z-338 on:

1. Type and severity of symptoms a standardized nutrient challenge

2. The gastric nutrient distribution and gastric emptying of a standardized nutrient
challenge

3. The association of the above with the manifestations of symptoms and symptom pattern
Trial website
https://clinicaltrials.gov/ct2/show/NCT00298194
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerald Holtmann, Professor
Address 0 0
Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT00298194