| CTRI Number |
CTRI/2024/09/073256 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study and compare the effect of two different antibiotic regimen in treating Helicobacter pylori infection. |
|
Scientific Title of Study
|
High Dose Dual Therapy Vs. Standard Triple Therapy in the Eradication of Helicobacter Pylori: A Randomized Controlled 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 |
Geetankshi Gopal Ghabru |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute Of Postgraduate Medical Education and Research Dhanvantri Nagar Puducherry |
| Address |
Department of Surgery
Jawaharlal Institute Of Postgraduate Medical Education and Research
Dhanvantri Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8627063958 |
| Fax |
|
| Email |
geetankshisharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIikram Kate |
| Designation |
Professor (Senior Scale) |
| Affiliation |
JMedical Education and Research |
| Address |
Dean Academic JIPMER
Academic Section
Jawaharlal Institute of Postgraduate Medical Education and Research,
Dhanavantri Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487781661 |
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anandhi A |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Surgery
Jawaharlal Institute of Postgraduate
Medical Education and Research,
Dhanavantri Nagar
Puducherry
Dhanvantri Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487781661 |
| Fax |
|
| Email |
anandhiramesh76@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Intramural Research Fund Committee, JIPMER, Puducherry, 605006 |
|
|
Primary Sponsor
|
| Name |
Intramural Research Fund Committee |
| Address |
Intramural Research Fund Committee, JIPMER, Puducherry, 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 VIKRAM KATE |
Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry, 605006 |
Endoscopy Room, Ward-31,
Old Block,
Department of Surgery,
Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry
605006
Pondicherry
PONDICHERRY |
9843058013
drvikramkate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Interventional studies, Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry |
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 |
| Intervention |
Group A receiving High Dose Dual Therapy
(the test group) |
Group A participants will receive cap omeprazole 20mg four times a day and cap amoxicillin 1g four times a day for 14 days.
The effect of the treatment i.e High Dose Dual Therapy shall be studied six weeks following the therapy. The effect will be compared with the Group B to look for which treatment is effective.
This study arm will recruit 84 patients for declaring superiority to the control group at two percent margin of superiority and including ten percent loss in each arm. |
| Comparator Agent |
Group B receiving Standard Triple therapy
(active control group) |
Participants of Group B will receive capomeprazole 20 mg twice daily, cap amoxicillin 1 gram twice a day and tabclarithromycin 500 mg twice a day for 14 days. the effect of the standard dual therapy shall be studied six weeks following surgery. The effect of the treatment will be compared with the study group A to look for which treatment is more effective and hence draw a result. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients more than 18 years of age who undergo esophagogastroduodenoscopy for the investigation of gastrointestinal symptoms in the Department of Surgery, JIPMER and are tested positive for Helocobacter pylori infection. |
|
| ExclusionCriteria |
| Details |
1. Previous eradication therapy.
2. Patients who have used antibiotics within the previous 4 weeks.
3. Past history of developing allergy to any antibiotic used in the study.
4. Patients who have undergone gastrectomy.
5. Coexisting of severe concomitant medical illness.
6. Pregnancy or lactating women.
7. Patients diagnosed with any malignancies.
8. Patients with portal gastropathy. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study design is designed as a superiority trial.
Aim is to compare the effectiveness of High Dose Dual Therapy in eradicating Helicobacter pylori infection.
Aim is to prove that the proposed regimen is superior to the Standard Triple therapy in eradiacting the Helicobacter pylori Infection, with a level of significance of 5 percent and margin of superiority of 2 percent. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the compliance & adverse effects of High Dose Dual Therapy & Standard Triple Therapy. |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
05/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study is a randomised control trial to compare the efficacy of high dose dual therapy and the standard triple therapy in eradication of Helicobacter pylori infection. It also aims to compare the compliance and adverse effects related to the drug regimens proposed for the study. Patient undergoing upper gastrointestinal endoscopy in Department of Surgery shall be enrolled for the study if they the inclusion criteria. Convenient sampling shall be done and after obtaining the informed consent, patient shall receive either of the two drug regimens for a period of 14 days. High dose dual therapy- participants shall receive omeprazole 20 mg four times a day and amoxicillin 1 gram four times a day for 14 days Standard triple therapy- participants shall receive omeprazole 20 mg twice a day, amoxicillin 1 gram twice a day and clarithromycin 500 mg twice a day for 14 days. Assessment of the efficacy shall be done 6 weeks later following the treatment by doing stool antigen test in a case of non ulcer disease and a repeat upper gastrointestinal endoscopy in a case of ulcer disease. |