Trial Profile

A Multi-centre, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Phase 4 Efficacy and Safety Study of P-CAB (Tegoprazan 50 mg Once Daily) Compared With PPI (Rabeprazole 20 mg Once Daily) to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease

Status: Recruiting

Phase of Trial: Phase IV

Latest Information Update: 14 Jun 2025

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At a glance

Drugs Tegoprazan (Primary) ; Rabeprazole
Indications Duodenal ulcer; Gastric haemorrhage; Gastric ulcer; Gastro-oesophageal reflux; Gastrointestinal ulcer
Focus Therapeutic Use
Acronyms PROTECT-HBR

18 Mar 2025 Planned number of patients changed from 3100 to 3320.
20 Sep 2023 Planned End Date changed from 31 Dec 2025 to 31 Dec 2027.
20 Sep 2023 Planned primary completion date changed from 30 Sep 2025 to 30 Sep 2026.

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