| CTRI Number |
CTRI/2026/03/106498 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study Comparing Two Treatments (Vonoprazan and Esomeprazole) for H. pylori Infection in Patients in Eastern India |
|
Scientific Title of Study
|
Comparison of Safety and Efficacy of Vonoprazan based High dose amoxicillin dual therapy with Esomeprazole based Standard triple therapy for H pylori eradication in Eastern India: A single centre double blind Randomized trial |
| 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 Sanjib Kumar Kar |
| Designation |
Senior Consultant |
| Affiliation |
Indian Institute of Gastroenterology and Hepatology |
| Address |
Room No 209, Department Of Gastroenterology, Endoscopy Division,Service Road NH 16 Unit27 Gandarpur,sikharpur,Cuttack.
Cuttack ORISSA 753003 India |
| Phone |
07978900184 |
| Fax |
|
| Email |
drsanjibkar@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjib Kumar Kar |
| Designation |
Senior Consultant |
| Affiliation |
Indian Institute of Gastroenterology and Hepatology |
| Address |
Room No 209, Department Of Gastroenterology, Endoscopy Division,Service Road NH 16 Unit27 Gandarpur,sikharpur,Cuttack.
ORISSA 753003 India |
| Phone |
07978900184 |
| Fax |
|
| Email |
drsanjibkar@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanjib Kumar Kar |
| Designation |
Senior Consultant |
| Affiliation |
Indian Institute of Gastroenterology and Hepatology |
| Address |
Room No 209, Department Of Gastroenterology, Endoscopy Division,Service Road NH 16 Unit27 Gandarpur,sikharpur,Cuttack.
ORISSA 753003 India |
| Phone |
07978900184 |
| Fax |
|
| Email |
drsanjibkar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indian Institute of Gastroenterology and Hepatology,Service Road NH 16 Unit27
Gandarpur,sikharpur,Cuttack,753003,Odisha,India |
|
|
Primary Sponsor
|
| Name |
Dr Sanjib Kumar Kar |
| Address |
Room No 209, Department Of Gastroenterology, Endoscopy
Division,Service Road NH 16 Unit27 Gandarpur,sikharpur,Cuttack,Odisha,India,753003 |
| 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 Sanjib Kumar Kar |
Indian Institute Of Gastroenterology And Hepatology |
Room No 209,
Department Of
Gastroenterology,
Endoscopy
Division,Service Road
NH 16 Unit27 Gandarp
ur,sikharpur,Cuttack
Cuttack, ORISSA Cuttack ORISSA |
07978900184
drsanjibkar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,Indian Institute of Gastroenterology and Hepatology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Esomeprazole Based triple therapy group |
The 14days of standard Esomeprazole Based triple therapy group will receive, esomeprazole enteric-coated tablets 20 mg twice daily, amoxicillin capsules 1000 mg twice daily, clarithromycin sustained release tablets 500 mg twice daily. Patients will be instructed to take esomeprazole half an hour before meals, while amoxicillin and clarithromycin to be taken half an hour after meals. |
| Intervention |
Vonoprazan based High dose amoxicillin dual therapy(HDDT) |
14days of Vonoprazan-based HDDT, comprising Vonoprazan fumarate tablets 20 mg Two times daily and amoxicillin capsules 1000 mg three times daily. Patients will be instructed to take vonoprazan, amoxicillin 30 minutes after meals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age range of 18 to 90 years
2. Confirmed H. pylori infection by at least one of the following diagnostic methods: Carbon-14 urea breath test (14C UBT) or immuno-histochemical staining of biopsy specimens. When the disintegrations per minute (DPM) more than 49 (14C), H. pylori was considered positive
3. No use of antibiotics, bismuth, or Indian traditional medicines within four weeks prior to 14C-UBT, and no use of H2 receptor antagonists, PPIs, P-CAB, or other drugs affecting H. pylori activity within two weeks before 14C UBT
4. No prior history of H. pylori eradication therapy
|
|
| ExclusionCriteria |
| Details |
1. Patients with serious diseases or clinical conditions that may interfere with the evaluation of study results, such as severe heart, liver, lung, and renal insufficiency, or compromised immunity
2. Patients with allergies to penicillin or any study-related medications
3.Patients with mental illness or communication disorders
4. Pregnant or lactating patients
5. Patients with severe gastrointestinal diseases, including gastrointestinal tumors, gastrointestinal bleeding, or other organic diseases; and
6. Patients concurrently participating in other clinical trials
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare eradication rates of 14-day Vonoprazan based High dose amoxicillin dual therapy with 14-day Esomeprazole Based Standard Triple therapy in H. pylori Infected patient. |
proportion of H. pylori negative patients in specific groups at least 4 weeks after treatment completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare adverse events, compliance, symptom relief and cost-effectiveness of 14-day Vonoprazan based High dose amoxicillin dual therapy with 14-day Esomeprazole Based Standard Triple therapy for H. pylori eradication |
At least 4 weeks after treatment completion |
|
|
Target Sample Size
|
Total Sample Size="530" Sample Size from India="530"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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
|
Helicobacter pylori is a gram-negative microaerophilic bacterium that colonizes the human stomach and remains highly prevalent worldwide. Although the global prevalence has declined in recent decades, H. pylori infection continues to be a major public health problem and is associated with peptic ulcer disease, chronic gastritis, and progression to gastric cancer. Successful eradication of the infection can reduce gastric mucosal damage and lower the risk of gastric malignancy.
Currently recommended eradication regimens include clarithromycin-based triple therapy and bismuth-containing quadruple therapy. However, these regimens are increasingly limited by rising antibiotic resistance, particularly to clarithromycin, metronidazole, and levofloxacin, as well as issues related to multiple drug combinations, increased adverse effects, and poor patient compliance.
High-dose amoxicillin dual therapy combined with potent acid suppression has emerged as a promising alternative approach. Recently, Vonoprazan, a potassium-competitive acid blocker, has shown stronger and more sustained acid inhibition compared with traditional proton pump inhibitors such as Esomeprazole. This may improve the efficacy of amoxicillin-based dual therapy.
However, evidence comparing vonoprazan-based high-dose dual therapy with standard proton pump inhibitor-based triple therapy in the Indian population is limited. Therefore, this randomized controlled trial aims to evaluate the safety and efficacy of these treatment regimens for H. pylori eradication in Eastern India. |