drugset / Trial / NCT02788123

A Study To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Subjects With Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Induced Gastropathy

NCT02788123 ↗

Phase 4 Terminated 9 enrolled Astellas Pharma Europe B.V.
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to evaluate clinical efficacy of bismuth tripotassium dicitrate (De-Nol) in combination with pantoprazole versus pantoprazole monotherapy in subjects with NSAID-induced gastropathy in 14±2 days of treatment.

Timeline

Start
2017-03-03
Primary completion
2017-05-29
Completion
2017-06-13

Outcome

Outcome not reported

Stopped (Business): “Internal reassessment of the medicinal product development strategy by Sponsor”

Drugs

EvaluationDrugModalityDoseRoute
Subject Pantoprazole Other / unclassified — Oral
Subject bismuth tripotassium dicitrate Unknown — Oral

Indications