Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000454673
Ethics application status
Approved
Date submitted
11/09/2005
Date registered
21/09/2005
Date last updated
21/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the use of nizatidine (Tazac) as a prokinetic agent improve gastric emptying in patients who have had an oesophagectomy for oesophageal cancer?
Scientific title
Does the use of nizatidine (Tazac) as a prokinetic agent improve gastric emptying in patients who have had an oesophagectomy for oesophageal cancer?
Secondary ID [1] 173 0
Study Number 07-09-08-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed gastric emptying post oesophagectomy for oesophageal cancer 569 0
Condition category
Condition code
Cancer 645 645 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention code [1] 457 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 756 0
To see if there is a statistically significant improvement in gastric emptying by 20% with the use of nizatidine, compared with baseline function after one week of use.
Timepoint [1] 756 0
Secondary outcome [1] 1550 0
To assess patients' quality of life and eating comfort
Timepoint [1] 1550 0
Prior to the start of the study, and after one week on nizatidine.

Eligibility
Key inclusion criteria
6 months or more post oesophagectomy- written consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to nizatidine- patients undergoing further treatment for oesophageal cancer- patients who are mentally or legally incapacitated- all pregnant women or potentially pregnant women.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 705 0
Other
Name [1] 705 0
Cabrini Clinical Education and Research Institute Council
Country [1] 705 0
New Zealand
Primary sponsor type
Other
Name
Cabrini Clinical Education and Research Institute
Address
Country
Australia
Secondary sponsor category [1] 590 0
University
Name [1] 590 0
Cabrini Monash University Department of Surgery
Address [1] 590 0
Country [1] 590 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1907 0
Cabrini Human Research Ethics Committee Department of Human Services - Radiation Safety Program
Ethics committee address [1] 1907 0
Ethics committee country [1] 1907 0
Australia
Date submitted for ethics approval [1] 1907 0
Approval date [1] 1907 0
Ethics approval number [1] 1907 0

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

Contacts
Principal investigator
Name 36300 0
Address 36300 0
Country 36300 0
Phone 36300 0
Fax 36300 0
Email 36300 0
Contact person for public queries
Name 9646 0
Dr Jennifer Chong
Address 9646 0
Cabrini Hospital
Suite 20
183 Wattletree Road
Malvern VIC 3144
Country 9646 0
Australia
Phone 9646 0
+61 3 95081651
Fax 9646 0
+61 3 95081657
Email 9646 0
[email protected]
Contact person for scientific queries
Name 574 0
Mr Simon Woods
Address 574 0
Cabrini Hospital
Suite 20
183 Wattletree Road
Malvern VIC 3144
Country 574 0
Australia
Phone 574 0
+61 3 95761411
Fax 574 0
+61 3 95761414
Email 574 0
[email protected]

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.