NCT00175045

Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis

A Phase 2, Open-Label Multicenter Study to Evaluate the Pharmacodynamics of Intravenous Lansoprazole to That of Oral Lansoprazole in Subjects With Erosive Esophagitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare the pharmacodynamics of intravenous (IV) lansoprazole to oral lansoprazole capsules, once daily (QD), in participants with erosive esophagitis.

Detailed description

Phase 2, open label, multi-center, 2-period study to compare the pharmacodynamics of IV lansoprazole 30 mg to oral lansoprazole 30 mg in subjects with erosive esophagitis (grade \>or= 2)diagnosed by endoscopy.

Conditions

• Esophagitis
• Reflux

Interventions

Type	Name	Description
DRUG	Lansoprazole	Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.
DRUG	Lansoprazole	Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days.

Timeline

• Start date: 2003-06-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2005-09-15
• Last updated: 2010-07-21