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
The purpose of this project is to see whether nizatidine, a drug commonly used to treat peptic ulcers and reflux disease, may improve the emptying of the stomach in patients who have had an operation for oesophageal cancer. Participation in this project involves taking the trial medication for one week and having a special gastric empyting scan before and after one week of treatment with the drug. The scan involves a small dose of radiation which has been approved by the Department of Human Services, Radiation Safety Approval.
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
jwcho7@hotmail.com
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
woods@surgicalconsulting.com.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.