| CTRI Number |
CTRI/2025/07/091209 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Vonoprazan and Omeprazole for Healing Stomach Ulcers |
|
Scientific Title of Study
|
Efficacy and Safety of Vonoprazan versus Omeprazole in Pharmacotherapy of H. pylori-Induced Peptic Ulcer in Eastern India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bazla Nazir |
| Designation |
Junior resident |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences |
| Address |
Department of Pharmacology, 3rd floor, academic building, IGIMS, Sheikhpura, Patna- 800014
Al- Hira campus, Shahganj, Patna-800006
Patna
BIHAR
800006
India |
| Phone |
8340460989 |
| Fax |
|
| Email |
bazlanazir4689@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Kumar |
| Designation |
Additional Professor |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences |
| Address |
Department of Pharmacology, 3rd floor, Academic building, IGIMS, Sheikhpura, Patna-800014
Patna
BIHAR
800014
India |
| Phone |
9304093698 |
| Fax |
|
| Email |
manu072@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bazla Nazir |
| Designation |
Junior resident |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences |
| Address |
Department of Pharmacology, 3rd floor, academic building, IGIMS, Sheikhpura, Patna- 800014
Al- Hira campus, Shahganj, Patna-800006
Patna
BIHAR
800006
India |
| Phone |
8340460989 |
| Fax |
|
| Email |
bazlanazir4689@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Bazla Nazir |
| Address |
Department of Pharmacology, 3rd floor, Academic building, IGIMS, Sheikhpura, Patna- 800014 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bazla Nazir |
Indira Gandhi Institute of Medical Sciences |
Unit IV, Department of General Medicine, Ground Floor, Medicine Block, IGIMS, Sheikhpura, Patna-800014
Patna
BIHAR |
8340460989
bazlanazir4689@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,IGIMS,Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K279||Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Omeprazole |
Omeprazole 20mg + Amoxicillin 750 mg + Metronidazole 400mg twice daily for 14 days, PO |
| Intervention |
Vonaprazan |
Intervention drugs: Vonoprazan 20mg + Amoxicillin 750 mg + Metronidazole 400mg twice daily for 14 days, PO
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to provide informed consent and adhere to study protocols.
Patients with a confirmed diagnosis of H. pylori infection via urea breath test, stool antigen test, or histological examination.
|
|
| ExclusionCriteria |
| Details |
1.Patients with a history of allergy or intolerance to vonoprazan, omeprazole, or related compounds.
2.Patients currently using other proton pump inhibitors or H2 receptor antagonists within 2 weeks before the study.
3.Patients with a history of gastric surgery or previous H. pylori eradication therapy.
4.Patients with severe comorbidities such as liver, kidney, or heart diseases.
5.Pregnant or lactating women.
6.Patients unable or unwilling to comply with study procedures and follow-up visits
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients achieving clinical cure (resolution of peptic ulcer symptoms) at the end of pharmacotherapy (14th day) for Vonoprazan triple therapy compared to Omeprazole triple therapy. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| H. pylori eradication (negative UBT and RUT post-treatment) |
baseline and 2 weeks |
| Endoscopic grading (Forrest Classification) |
baseline and 2 weeks |
| quality of life assessment using validated tool: SF-36 |
2 weeks |
| Incidence of adverse effects using WHO UMC causality assessment scales |
baseline to 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial investigates the comparative efficacy and safety of vonoprazan versus omeprazole, both combined with amoxicillin and metronidazole, for treating H. pylori-induced peptic ulcer disease (PUD) in Eastern India. Targeting the challenges of PPI resistance and regional treatment inefficacy, it evaluates clinical cure rates, H. pylori eradication (via UBT/RUT), endoscopic ulcer grading, patient-reported outcomes, and adverse event profiles across 100 adult participants. With vonoprazan’s CYP2C19-independent, rapid, and sustained acid suppression effects, the study hypothesizes superior symptom relief, ulcer healing, and tolerability compared to omeprazole. Outcomes may inform improved clinical guidelines and tailored therapeutic strategies for high-burden populations. |