NCT00471094

Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis

A Phase 2 Study to Evaluate the Safety and Efficacy of Ilaprazole (5 mg QD, 20 mg QD and 40 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 831 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of 8 weeks of daily treatment with Ilaprazole (5, 20 and 40 mg), once daily (QD), compared to lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

Detailed description

This 8 week study will be conducted by approximately 160 investigators in the United States. During this study, esophagitis healing will be evaluated by endoscopy, heartburn and other symptom relief will be evaluated by questionnaire and study drug levels will be measured.

Conditions

• Esophagitis

Interventions

Type	Name	Description
DRUG	Ilaprazole	Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
DRUG	Ilaprazole	Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
DRUG	Ilaprazole	Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
DRUG	Lansoprazole	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2007-05-09
• Last updated: 2012-02-02

Locations

94 sites across 1 country: United States