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NCT04901663 Clinical Trial

Vonoprazan in Helicobacter Pylori Treatment an RCT

Helicobacter Pylori Infection Clinical Trial

Official title:
Comparison of Vonoprazan and Amoxicillin Dual Therapy With Standard Triple Therapy With Proton Pump Inhibitor for Helicobacter Pylori Eradication; a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04901663
Other study ID # BAD-VPZ-001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 21, 2021
Est. completion date August 16, 2021

Study information
Verified date August 2021
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RCT for comparison of Standard Triple therapy (Omeprazole+Amoxil+Clarithromycin) for H Pylori erradication with Vonoprazan+Amoxil dual therapy.

Description:

OBJECTIVE To compare the efficacy of Vonoprazan based dual treatment versus PPI based treatment for the eradication of Helicobacter pylori infection. OPERATIONAL DEFINITION Helicobacter Pylori infection: Hp infection will be labelled by any one of following investigation: - Helicobacter Pylori Stool Antigen - Histopathology on Giemsa Stain MATERIAL AND METHODS: Study Design: Randomized control trial. Setting: This study will be conducted in the Medical OPD and Medical Unit 1 of Dr. Ruth K.M. Pfau, Civil Hospital Karachi affiliated with Dow University of Health Sciences DATA COLLECTION PROCEDURE: All patients presenting to the OPD or Medical Unit 1 of Dr. Ruth KM Pfau, Civil Hospital Karachi and fulfilling the inclusion criteria will be included after taking informed consent. The participants will be randomly allocated to 2 groups with help of random number table and will be treated for 2 weeks. Group A: will be given: Capsule Amoxicillin 1 gm twice daily Tablet Clarithromycin 500 mg twice a day Capsule Omeprazole 20 mg twice a day Group B will be given: Capsule Amoxicillin 1 gm twice daily Tablet Vonoprazan 20 mg twice a day Confirmation of Hp eradication will be done by stool Hp antigen test 4 weeks after completion of treatment. DATA ANALYSIS Data will be stratified according to age & gender. Frequency of gender & mean (SD) of age will be compared between groups using Pearson's Chi-square test and Student's t-test respectively. Frequency of Hp eradication between two groups will be compared using Pearson's chi-square test. A p value < .05 will be taken as significant.

Recruitment information / eligibility
Status Completed
Enrollment 179
Est. completion date August 16, 2021
Est. primary completion date August 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Helicobacter Pylori Positive by any one of following: Histopathology by Giemsa Stain Stool Antigen Exclusion Criteria: - • Previous surgery of the stomach such as partial gastrectomy. - Allergy to any of the antibiotics used in the study. - Intake of antibiotics, PPIs, corticosteroids, or nonsteroidal anti-inflammatory drugs within the last 2 weeks. - Pregnant or lactating females. - Alcohol abuse or drug addiction. - Severe neurological or psychiatric disorder.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG
Orally twice daily for 2 weeks
• Vonoprazan 20 MG; Amoxicillin 1000 MG
Orally twice daily for 2 weeks

Locations
Country Name City State
Pakistan Dr Ruth KM Pfau Civil Hospital Karachi Karachi Sindh

Sponsors (1)
Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

Abadi ATB, Ierardi E. Vonoprazan and Helicobacter pylori Treatment: A Lesson From Japan or a Limited Geographic Phenomenon? Front Pharmacol. 2019 Apr 5;10:316. doi: 10.3389/fphar.2019.00316. eCollection 2019. Review. — View Citation

Burucoa C, Axon A. Epidemiology of Helicobacter pylori infection. Helicobacter. 2017 Sep;22 Suppl 1. doi: 10.1111/hel.12403. Review. — View Citation

Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. Review. — View Citation

Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 20 — View Citation

Kato M, Ota H, Okuda M, Kikuchi S, Satoh K, Shimoyama T, Suzuki H, Handa O, Furuta T, Mabe K, Murakami K, Sugiyama T, Uemura N, Takahashi S. Guidelines for the management of Helicobacter pylori infection in Japan: 2016 Revised Edition. Helicobacter. 2019 — View Citation

Ke H, Li J, Lu B, Yang C, Wang J, Wang Z, Liu L, Chen Y. The appropriate cutoff gastric pH value for Helicobacter pylori eradication with bismuth-based quadruple therapy. Helicobacter. 2021 Feb;26(1):e12768. doi: 10.1111/hel.12768. Epub 2020 Oct 21. — View Citation

Muñoz N, Sánchez-Delgado J, Baylina M, López-Góngora S, Calvet X. Prevalence of Helicobacter pylori resistance after failure of first-line therapy. A systematic review. Gastroenterol Hepatol. 2018 Dec;41(10):654-662. doi: 10.1016/j.gastrohep.2018.06.014. — View Citation

Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind — View Citation

Suzuki H, Mori H. World trends for H. pylori eradication therapy and gastric cancer prevention strategy by H. pylori test-and-treat. J Gastroenterol. 2018 Mar;53(3):354-361. doi: 10.1007/s00535-017-1407-1. Epub 2017 Nov 14. Review. — View Citation

Wang YC, Chen YP, Ho CY, Liu TW, Chu CH, Wang HY, Liou TC. The Impact of Gastric Juice pH on the Intraluminal Therapy for Helicobacter pylori Infection. J Clin Med. 2020 Jun 14;9(6). pii: E1852. doi: 10.3390/jcm9061852. — View Citation

Yamada S, Kawakami T, Nakatsugawa Y, Suzuki T, Fujii H, Tomatsuri N, Nakamura H, Sato H, Okuyama Y, Kimura H, Yoshida N. Usefulness of vonoprazan, a potassium ion-competitive acid blocker, for primary eradication of Helicobacter pylori. World J Gastrointe — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Helicobacter Pylori Eradication Stool Heliobacter Pylori Antigen = Negative 4 weeks
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