Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000493549
Ethics application status
Approved
Date submitted
22/04/2015
Date registered
19/05/2015
Date last updated
19/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cure rate and side effects comparison between the sequential bismuth based quadruple therapy and the concomitant bismuth based quadruple therapy in treating patients carrying antibiotic resistant Helicobacter pylori strain.
Scientific title
Efficacy of sequential bismuth based quadruple therapy versus concomitant bismuth based quadruple therapy in treating patients carrying antibiotic resistant Helicobacter pylori strain.
Secondary ID [1] 286585 0
Nil known
Universal Trial Number (UTN)
U1111-1169-5022
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Helicobacter pylori unable to be eradicated with standard triple therapies. 294855 0
Condition category
Condition code
Oral and Gastrointestinal 295115 295115 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 295153 295153 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
sequential treatment (5 days of rabeprazole 20 mg three times a day and bismuth subcitrate (BIS) 240mg four times a day, followed by 5 days of rabeprazole 20 mg three times a day, BIS 240mg four times a day, rifabutin (RFB) 150 mg twice a day and ciprofloxacin (CIP) 500 mg twice a day.); All drugs are to be taken orally; Patients compliance was checked via phone interview.

Intervention code [1] 291725 0
Treatment: Drugs
Comparator / control treatment
concomitant treatment (10 days of rabeprazole 20 mg three times a day, BIS 240mg four times a day, RFB 150 mg twice a day and CIP 500 mg twice a day).
Control group
Dose comparison

Outcomes
Primary outcome [1] 294883 0
Treatment success, assessed by percentage of cured patients.
Timepoint [1] 294883 0
Because the followup diagnosis of these patients can vary from a month to several months and the rarity of reinfection of this organism, we would accept all patient's follow up diagnostic results up to two years.
Secondary outcome [1] 314281 0
side effects comparison between the test group (sequential quadruple therapy) and the control group (concomitant quadruple therapy).

side effects data are collected based on a 5 min survey designed specifically for this study.

Most common side effects include, nausea, diarrhea, stomach pain, headache and dry mouth.
Timepoint [1] 314281 0
survey is given immediately after completion of treatment.

Eligibility
Key inclusion criteria
Patients must fail more than one standard triple therapy, which indicate carrying antibiotic resistant H. pylori strain.
If antibiotic sensitivity testing was performed, the strain must be sensitive to Ciprofloxacin and Rifabutin.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
free of H. pylori infection, mental disability, pregnancy or lactation in women, known allergy or hypersensitivity to drugs used in study therapy, or current participation with other clinical trials.

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)
allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Chi-square analysis to compare cure rate between two treatment groups.

student T-test to compare the overall side effects between two treatment groups.

We planned to use 2x2 contingency Chi square tests to compare the cure rates for the two regimens, and set the significance level at 0.05. From previous published work we knew the expected cure rate for concurrent PBRC treatment regimen (94%). We undertook power analysis to determine the number of participants needed to achieve a high power (> 0.90) to pick-up a 75 % cure rate with the new regimen (sequential PBRC), with a cure rate held at 94% for the concurrent regimen. This outcome represents an effect size of just over 0.25 (for an effect size of 0.25, the sample size is 203). Hence, we ascertained that the sample size should be approximately 200.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2012
Actual
18/01/2012
Date of last participant enrolment
Anticipated
31/12/2013
Actual
10/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3727 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 9601 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 291145 0
Government body
Name [1] 291145 0
Western Australian Government’s Department of Commerce
Country [1] 291145 0
Australia
Funding source category [2] 291146 0
Government body
Name [2] 291146 0
Western Australian Government’s Department of Health
Country [2] 291146 0
Australia
Funding source category [3] 291147 0
Government body
Name [3] 291147 0
National Health and Medical Research Council
grant number 572723
Country [3] 291147 0
Australia
Funding source category [4] 291148 0
University
Name [4] 291148 0
University of Western Australia’s Special Infrastructure Fund
Country [4] 291148 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35, Stirling Highway, Crawley 6009, WA
Country
Australia
Secondary sponsor category [1] 289849 0
None
Name [1] 289849 0
none
Address [1] 289849 0
none
Country [1] 289849 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292725 0
Sir Charles Gairdner and Osborne Park Health Care Group (SCGOPHCG)
Ethics committee address [1] 292725 0
Level 2 A Block, Hospital Ave, Nedlands, WA 6009
Ethics committee country [1] 292725 0
Australia
Date submitted for ethics approval [1] 292725 0
05/02/2013
Approval date [1] 292725 0
10/10/2013
Ethics approval number [1] 292725 0
2013-007
Ethics committee name [2] 292825 0
Sir Charles Gairdner and Osborne Park Health Care Group (SCGOPHCG)
Ethics committee address [2] 292825 0
Level 2 A Block, Hospital Ave, Nedlands, WA 6009
Ethics committee country [2] 292825 0
Australia
Date submitted for ethics approval [2] 292825 0
01/04/1999
Approval date [2] 292825 0
01/04/1999
Ethics approval number [2] 292825 0
1999-026

Summary
Brief summary
The primary aim of this study is to determine Efficacy of sequential bismuth based quadruple therapy versus concomitant bismuth based quadruple therapy in treating patients carrying antibiotic resistant Helicobacter pylori strain.
Trial website
Trial related presentations / publications
Tay CY, Windsor HM, Thirriot F, Lu W, Conway C, Perkins TT, et al. Helicobacter pylori eradication in Western Australia using novel quadruple therapy combinations. Alimentary pharmacology & therapeutics. 2012; 36(11-12): 1076-83.
Public notes
As mentioned in the Participant information sheet (PCIF), Page 2, this is an extension study from previous approved study, HREC 1999-026. Please find the closure of previous study in attachment.
Attachments [1] 411 411 0 0
/AnzctrAttachments/368419-Ethics approval 2013-007.pdf
Attachments [2] 412 412 0 0
/AnzctrAttachments/368419-Study protocol 040713.pdf
Attachments [3] 413 413 0 0
/AnzctrAttachments/368419-letter of invitation 050713.pdf
Attachments [4] 414 414 0 0
/AnzctrAttachments/368419-PCIF 170913 - Copy.docx
Attachments [5] 415 415 0 0
/AnzctrAttachments/368419-Treatment side effect form 200613.pdf
Attachments [6] 458 458 0 0
/AnzctrAttachments/368419-Closure of 99-026 project.pdf

Contacts
Principal investigator
Name 56734 0
Dr Alfred Chin Yen Tay
Address 56734 0
University of Western Australia
M504, 35 Stirling Highway, Crawley, WA 6009,
Country 56734 0
Australia
Phone 56734 0
+61 8 93464817
Fax 56734 0
Email 56734 0
alfred.tay@uwa.edu.au
Contact person for public queries
Name 56735 0
Dr Alfred Chin Yen Tay
Address 56735 0
University of Western Australia
M504, 35 Stirling Highway, Crawley, WA 6009,
Country 56735 0
Australia
Phone 56735 0
+61 8 93464817
Fax 56735 0
Email 56735 0
alfred.tay@uwa.edu.au
Contact person for scientific queries
Name 56736 0
Dr Alfred Chin Yen Tay
Address 56736 0
University of Western Australia
M504, 35 Stirling Highway, Crawley, WA 6009,
Country 56736 0
Australia
Phone 56736 0
+61 8 93464817
Fax 56736 0
Email 56736 0
alfred.tay@uwa.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

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