A clinical trial to compare and study the effects of pantoprazole versus placebo in patients of acute caustic ingestion

Efficacy of pantoprazole versus placebo in mucosal healing and change in endoscopic grading in patients of acute caustic ingestion :A Randomised Controlled Open Label Study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065100

Enrollment

Registered

2024-04-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: T287- Corrosion of other parts of alimentary tract

Interventions

Intervention1: Pantoprazole: Intravenous pantoprazole 80 mg stat followed by 8 mg per hour intravenous infusion for 72 hours Control Intervention1: Normal saline: Intravenous 100 ml normal saline dai

Eligibility

Inclusion criteria

Inclusion criteria: 1. All consecutive patients with history of acute corrosive ingestion(within 48 hours of corrosive ingestion) 2. Age = 18 years 3. Valid consent given by the patient for the study

Exclusion criteria

Exclusion criteria: 1.Hemodynamically unstable patient 2.Patients who have received Cardio Pulmonary Resuscitation 3.Patients who need Endotracheal intubation and mechanical ventilation 4.Patients who are not conscious 5.History of corrosive ingestion of greater than 2 days 6.Age less than 18 years 7.Patients who refused to give valid consent for the study 8.Pregnancy

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of proton pump inhibitor (pantoprazole) versus placebo in the change in endoscopic grading in both intervention and control group after 3 daysTimepoint: To compare the efficacy of proton pump inhibitor (pantoprazole) versus placebo in the change in endoscopic grading in both intervention and control group after 3 days	—

Secondary

Measure	Time frame
To compare possible complications like infection, diarrhea, sepsis, stridor, hoarseness, upper gastrointestinal bleed, acute respiratory distress syndrome, acute kidney injury, perforation, peritonitis and mediastinitis in both intervention and control group.Timepoint: Upto 6 weeks to understand the outcome in terms of esophageal stricture formation and complications	—

Countries

India

Contacts

Public ContactDr Nayer Jamshed

AIIMS New Delhi

jamshednayer@gmail.com9990345682

Outcome results

None listed

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