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Comparison of efficacy and safety of 7-days vonoprazan versus 14-days esomeprazole based triple therapy for H- pylori infection

Protocol summary

Study aim
To compare the effect of 7-days Vonoprazan based triple therapy and 14-days Esomeprazole based triple therapy on the stool antigen test conversion from (positive to negative) in H. pylori infection To compare the effect of 7-days Vonoprazan based triple therapy and 14-days Esomeprazole based triple therapy on improvement of clinical symptoms in H. pylori infection To compare the effect of 7-days Vonoprazan based triple therapy and 14-days Esomeprazole based triple therapy on occurrence of any adverse effects in H. pylori infection
Design
Open label Prospective randomized controlled trial
Settings and conduct
Department of gastroenterology tertiary care hospital Rawalpindi Pakistan
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age above 18- years diagnosed for h-pylori by positive stool antigen test and Patients having symptoms of acid-peptic disease Both male and female patients nonpregnant females Exclusion criteria: Patient with history of drug allergy to either esomeprazole, Vonoprazan, penicillin’s or levofloxacin Previous h-pylori eradication therapy Pregnant and breast-feeding mothers Patient with serious CVS, liver, renal, pulmonary disorders, or acute malignancy History of gastric malignancy or surgery History of drug abuse History of using anti-biotics that affect h-pylori with in 4weeks
Intervention groups
Intervention group B: Vonoprazan 20mg BD based triple therapy with levofloxacin for 7 days Control group A: Esomeprazole 20 mg BD bsed triple thrapy with levofloxacin for 14 days
Main outcome variables
1. Conversion of stool antigen test from positive to negative 2. Clinical symptoms (dyspepsia) improvements 3. Antibiotic related adverse effects 4. Compliance of patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221207056738N1
Registration date: 2022-12-28, 1401/10/07
Registration timing: registered_while_recruiting

Last update: 2022-12-28, 1401/10/07
Update count: 0
Registration date
2022-12-28, 1401/10/07
Registrant information
Name
farzana waqar
Name of organization / entity
National university of medical sciences Rawalpindi
Country
Pakistan
Phone
+92 51 4251022
Email address
drfaru11@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-20, 1401/09/29
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of 7-days vonoprazan versus 14-days esomeprazole based triple therapy for H- pylori infection
Public title
Role of Vonaprazan in H.Pylori eradication
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Positive stool antigen test for h-pylori,endoscopic histopathological evidence of h-pylori. Age 18 years and above Both male and female patients presented with symptoms of dyspeps
Exclusion criteria:
Patient with history of drug allergy to either Pantoprazole, Vonoprazan Vonoprazan, penicillin’s or clarithromycin , Previous h-pylori eradication therapy, Pregnant and breast-feeding mothers, Patient with serious CVS, liver, renal, pulmonary disorders or acute malignancy, ,History of gastric malignancy or surgery, History of drug abuse. History of using anti-biotics that affect h-pylori with in 4 weeks
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 122
Randomization (investigator's opinion)
Randomized
Randomization description
Patient fulfilling inclusion criteria and after giving informed consent will be included study Method of randomization will be blocks generated by computer generated software Unit of randomization will be individual there will be no stratification of data Tools used in randomization will be www.randomize.net/ Algorithms.HTML The random sequence of block will be built in 1:1 parallel number Allocation concealment will not be carried out
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
there will be two groups of participants each group will contain 61 patients.one group will take 14-days triple therapy with esomeprazole 20mg BD,levofloxacin 500mg OD, amoxicillin 1000mg BD and the second group will take 7-days triple therapy with vonoprazan 20mg BD, levofloxacin 500mg OD, amoxicillin 1000mg BD. adverse effect of both therapies will be assessed at day -3 and day-14 through telephone. stool antigen test will be repeated after 28 days of the therapy

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional review committee
Street address
The mall parking lot,abid majeed road Rawalpindi Punjab
City
Rawalpindi
Postal code
44000
Approval date
2022-11-22, 1401/09/01
Ethics committee reference number
ERC/ID/233

Health conditions studied

1

Description of health condition studied
Helicobacter pylori infection is a condition in which gram -ve bacteria called H- pylori reside in mucus lining of stomach lead to gastritis, ulcer manifest in the form of dyspepsia
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere

Primary outcomes

1

Description
Conversion of stool antigen from positive to negative
Timepoint
After 4 weeks after the therapy
Method of measurement
Lab investigation. clinical assessment for symptoms improvement and side effects

Secondary outcomes

1

Description
Improvement of clinical symptoms, side effects ,drug compliance,tolerability
Timepoint
2 and 4 weeks after intervention
Method of measurement
Through telephone and after 4 weeks at hospital OPD

Intervention groups

1

Description
Intervention group: group 2 is the interventional group to which 7-days vonoprazan based triple therapy, new drug regimen, vonoprazn 20mg BD, amoxicillin 1000mg BD, levofloxacin 500mg OD for 7-days will be given.
Category
Treatment - Drugs

2

Description
Control group: Control group 1 in which 14-days esomeprazole based conventional triple therapy with esomeprazole 20mg BD, amoxicillin 1000mg BD, levofloxacin 500mg OD for 14-days will be given
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of gastroenterology tertiary care hospital rawapindi
Full name of responsible person
Farzana Waqar
Street address
The Mall,parking lot,Abid Majeed road Rawalpindi Punjab
City
Rawalpindi
Postal code
44000
Phone
+92 332 5881278
Email
drfaru11@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National university of Medical Sciences Rawalpindi
Full name of responsible person
Dr Mudassar Noor
Street address
25 b, RR camp Rawalpindi
City
Rawalpindi
Postal code
44000
Phone
+92 333 3693588
Email
smillingdr@yahoo.com
Grant name
research grant for post graduate trainee
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National university of Medical Sciences Rawalpindi
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
National University of Medical Sciences Rawalpindi
Full name of responsible person
Farzana Waqar
Position
Post Graduate Trainee
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
House no 357 street 47A Phase 2 Margalla Town Islamabad
City
Islamabad
Province
Punjab
Postal code
44000
Phone
+92 51 4251022
Email
drfaru11@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
NUMS
Full name of responsible person
Farzana Waqar
Position
Post Graduate Trainee
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
House no 357 street 47A Phase 2 Margalla town Islamabad
City
Islamabad
Province
Punjab
Postal code
44000
Phone
+92 51 4251022
Email
drfaru11@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
NUMS
Full name of responsible person
Farzana waqar
Position
Post Graduate Trainee
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
House no 357 Street 47A Phase 2 Margalla Town Islamabad
City
Islamabad
Province
Punjab
Postal code
44000
Phone
+92 51 4251022
Email
drfaru11@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
statistical analysis, results and conclusions of the study will be available online
When the data will become available and for how long
After completion of data collection. approximately by March 2023
To whom data/document is available
Data will be kept safe with the principal investigator
Under which criteria data/document could be used
Through data sheets
From where data/document is obtainable
drfaru11@gmail.com
What processes are involved for a request to access data/document
Contact the principal Invetigator
Comments
not applicable
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