drugset / Trial / NCT01281501

Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

NCT01281501 ↗

Phase 4 Completed 87 enrolled Chulalongkorn University
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the immediate synergistic effect on the relief of severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of oral antacid and antispasmodic agent (the conventional treatment).

Timeline

Start
2011-01
Primary completion
2011-10
Completion
2011-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Conventional vs Pantoprazole; p = 0.6; Mean Difference (Final Values) -2.6 (95% CI -12.7 to 7.4); t-test, 2 sided NCT01281501 ↗

paper There was no difference in the mean 60-minute visual analog scale scores between the treatment groups. PMID 22463973 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pantoprazole Other / unclassified 80 mg Intravenous
Background Aluminum hydroxide Unknown 1.32 g Oral
Background Hyoscine butylbromide Unknown 20 mg Intravenous
Background magnesium hydroxide Unknown 0.72 g Oral

Indications