Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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
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.