Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255164
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2005-11-15
Brief Title:
Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR 60 mg QD and 90 mg QD Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the ability of once-daily QD treatment with Dexlansoprazole modified-release MR 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis EE
Detailed Description:
This is a Phase 3 randomized double-blind multi-center placebo-controlled 6 month maintenance study The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR 60 mg and 90 mg with that of placebo in maintaining healing of erosive esophagitis
Because the development plan for Dexlansoprazole MR formulation was revised the results of 2 identical studies T-EE04-086 this study NCT00255164 and T-EE04-087 NCT00255151 were combined and analyzed as a single larger study referred to as study T-EE04-086 A total of 451 subjects were included in the combined analysis 237 subjects were enrolled into Study T-EE04-086 and 214 subjects were enrolled into Study T-EE04-087
Because the development plan for Dexlansoprazole MR formulation was revised the results of 2 identical studies T-EE04-086 this study NCT00255164 and T-EE04-087 NCT00255151 were combined and analyzed as a single larger study referred to as study T-EE04-086 A total of 451 subjects were included in the combined analysis 237 subjects were enrolled into Study T-EE04-086 and 214 subjects were enrolled into Study T-EE04-087
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1114-1355 | REGISTRY | WHO | None |