drugset / Trial / NCT01677338

Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects

NCT01677338 ↗

Phase 2 Completed 20 enrolled Otsuka Pharmaceutical Co., Ltd. Covance · collab
Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

This study is a multi-center, open-label comparison study and aimed to evaluate the preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying abnormal (delayed) gastric emptying rates in subjects.

Timeline

Start
2013-07
Primary completion
2014-06
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject 13C-uracil Unknown 100 mg Oral
Subject 99mTc sulfur colloid Diagnostic / imaging agent 500 unknown Oral

Indications