Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis
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|ClinicalTrials.gov Identifier: NCT00471094|
Recruitment Status : Completed
First Posted : May 9, 2007
Last Update Posted : February 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Esophagitis||Drug: Ilaprazole Drug: Lansoprazole||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||831 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
|Experimental: Ilaprazole 5 mg QD||
Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
|Experimental: Ilaprazole 20 mg QD||
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
|Experimental: Ilaprazole 40 mg QD||
Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
|Active Comparator: Lansoprazole 30 mg QD||
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
- The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy. [ Time Frame: Week 4 ]
- The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy. [ Time Frame: Week 8 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471094
|Study Director:||Medical Director||Takeda|