Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000427673
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
16/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gastric emptying and malnutrition in adults with cystic fibrosis
Scientific title
Gastric emptying and malnutrition in adults with cystic fibrosis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 536 0
Condition category
Condition code
Human Genetics and Inherited Disorders 616 616 0 0
Cystic fibrosis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Nuclear medicine gastric emptying study, questionaire, demographic indices.
Intervention code [1] 531 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 720 0
Nuclear medicine gastric emptying
Timepoint [1] 720 0
Secondary outcome [1] 1482 0
Nutritional indices
Timepoint [1] 1482 0

Eligibility
Key inclusion criteria
All adult cystic fibrosis patients.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 674 0
Charities/Societies/Foundations
Name [1] 674 0
CASS Foundation
Country [1] 674 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
CASS Foundation
Address
Country
Australia
Secondary sponsor category [1] 563 0
None
Name [1] 563 0
n/a
Address [1] 563 0
Country [1] 563 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35894 0
Address 35894 0
Country 35894 0
Phone 35894 0
Fax 35894 0
Email 35894 0
Contact person for public queries
Name 9720 0
Associate Professor John Wilson
Address 9720 0
Cystic Fibrosis Service
The Alfred Hospital
Prahran VIC 3181
Country 9720 0
Australia
Phone 9720 0
+61 3 92763600
Fax 9720 0
+61 3 92071050
Email 9720 0
john.wilson@med.monash.edu.au
Contact person for scientific queries
Name 648 0
Associate Professor John Wilson
Address 648 0
Cystic Fibrosis Service
The Alfred Hospital
Prahran VIC 3181
Country 648 0
Australia
Phone 648 0
+61 3 92763600
Fax 648 0
+61 3 9207 1050
Email 648 0
john.wilson@med.monash.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.