COMPARISON OF TWO TREATMENT REGIMENS, SEQUENTIAL THERAPY AND CONCOMITANT THERAPY FOR TREATMENT OF HELICOBACTER PYLORI IN PATIENTS WITH PERFORATED DUODENAL ULCER

A RANDOMIZED SINGLE BLIND CLINICAL TRIAL TO COMPARE THE ERADICATION RATE, PREVENTION OF ULCER RECURRENCE,SIDE EFFECT, PATIENT COMPLIANCE AND COST EFFECTIVENESS OF SEQUENTIAL VERSUS NON- BISMUTH CONCOMITANT QUADRUPLE THERAPY fOR TREATMENT OF HELICOBACTER PYLORI IN PATIENTS WITH PERFORATED DUODENAL ULCER

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003432

Enrollment

Registered

2013-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- PERFORATED DUODENAL ULCER PATIENTS WHO HAS UNDERGONE SIMPLE CLOSURE

Interventions

Intervention1: SEQUENTIAL DRUG THERAPY: LANSOPRAZOLE 30 MG BD + AMOXICILLIN 1 G BD FOR FIRST 5 DAYS. AND THEN LANSOPRAZOLE 30 MG BD + CLARITHROMYCIN 500 MG BD + METRONIDAZOLE 400MG TID FOR NEXT 5 DAYS

Eligibility

Inclusion criteria

Inclusion criteria: ALL CONSECUTIVE PATIENTS AGED MORE THAN 18 YEARS WITH PERFORATED DUODENAL ULCER FOLLOWING SIMPLE CLOSURE WITH H. PYLORI INFECTION

Exclusion criteria

Exclusion criteria: 1. GASTRIC ULCER PERFORATION 2. PATIENTS UNDERGOING ANY OTHER PROCEDURE APART FROM THE SIMPLE CLOSURE FOR PERFORATED DUODENAL ULCER. 3. PATIENTS WITH ASSOCIATED UPPER GI DISORDERS. 4. PATIENTS PRESENTING WITH REPERFORATION OR OTHER COMPLICATIONS.

Design outcomes

Primary

Measure	Time frame
COMPARISON OF THE ERADICATION RATES AND THE RATE OF ULCER RECURRENCE IN PATIENTS ADMINISTERED WITH SEQUENTIAL THERAPY AND CONCOMITANT THERAPY AT THREE, SIX AND TWELVE MONTHS FOLLOWING ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH PERFORATED DUODENAL ULCER FOLLOWING SIMPLE CLOSURE.Timepoint: AT 3,6 AND 12 MONTHS FOLLOWING STARTING DRUG THERAPY IN PATIENTS WITH PERFORATED DUODENAL ULCER FOLLOWING SIMPLE CLOSURE.	—

Measure

Time frame

COMPARISON OF THE ERADICATION RATES AND THE RATE OF ULCER RECURRENCE IN PATIENTS ADMINISTERED WITH SEQUENTIAL THERAPY AND CONCOMITANT THERAPY AT THREE, SIX AND TWELVE MONTHS FOLLOWING ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH PERFORATED DUODENAL ULCER FOLLOWING SIMPLE CLOSURE.Timepoint: AT 3,6 AND 12 MONTHS FOLLOWING STARTING DRUG THERAPY IN PATIENTS WITH PERFORATED DUODENAL ULCER FOLLOWING SIMPLE CLOSURE.

—

Secondary

Measure	Time frame
TO ASSESS AND COMPARE THE SIDE EFFECTS, THE PATIENT COMPLIANCE AND THE COST-EFFECTIVENESS OF THE SEQUENTIAL THERAPY VERSUS THE CONCOMITANT THERAPY IN ERADICATION OF HELICOBACTER PYLORI IN PERFORATED DUODENAL ULCER PATIENTS FOLLOWING SIMPLE CLOSURE. Timepoint: AFTER COMPLETION OF DRUG THERAPY	—

Countries

India

Contacts

Public ContactDr VIKRAM KATE

JIPMER

drvikramkate@gmail.com09843058013

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026