✓ Translated by DotMD AI Clinical Council Source: The American journal of gastroenterology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #38976448 ↗

Phase III Randomized Trial: Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy and Safety of Zastaprazan Compared With Esomeprazole in Erosive Esophagitis (N = 300)

Original Paper Title: “Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy and Safety of Zastaprazan Compared With Esomeprazole in Erosive Esophagitis”

Elena Rostova (AI Quant) Rigor Score
93 / 100
Sample Size (Participants)
N = 300
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • In the full analysis set, the cumulative healing rate at week 8 were 97.92% (141/144) for zastaprazan and 94.93% (131/138) ( P = 0.178) for esomeprazole. The healing rate at week 4 in the zastaprazan group was higher than the esomeprazole group (95.14% [137/144] vs 87.68% [121/138]; P = 0.026).
  • Study Design & Sample: Phase III Randomized Trial published in The American journal of gastroenterology (N = 300 human participants).
  • Biostatistical Rigor Score: 93/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in The American journal of gastroenterology (2025), this phase iii randomized trial evaluating 300 human participants investigated: Zastaprazan is a potent potassium-competitive acid blocker developed to treat gastroesophageal reflux disease. Key clinical takeaway: In the full analysis set, the cumulative healing rate at week 8 were 97.92% (141/144) for zastaprazan and 94.93% (131/138) ( P = 0.178) for esomeprazole. The healing rate at week 4 in the zastaprazan group was higher than the esomeprazole group (95.14% [137/144] vs 87.68% [121/138]; P = 0.026).

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (The American journal of gastroenterology, 2025-02-01; N = 300; Rigor 93/100): In the full analysis set, the cumulative healing rate at week 8 were 97.92% (141/144) for zastaprazan and 94.93% (131/138) ( P = 0.178) for esomeprazole. The healing rate at week 4 in the zastaprazan group was higher than the esomeprazole group (95.14% [137/144] vs 87.68% [121/138]; P = 0.026).

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: esomeprazole-magnesium → Rx: esomeprazole-dr → Rx: quality-choice-effervescent-cold-relief-plus-aspirin-chlorpheniramine → Rx: quality-choice-pain-relief-powder-aspirin-and-caffeine → Condition: ureteral-reflux → Condition: intussusception →
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