Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321737
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2006-05-02
Brief Title:
Efficacy and Safety of Dexlansoprazole MR Compared to Placebo 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 TAK-390MR 30 mg QD and 60 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 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis EE
Detailed Description:
This is a Phase 3 randomized double-blind multicenter placebo-controlled 6 month maintenance study The study is designed to compare the efficacy and safety of daily dexlansoprazole MR 30 mg and 60 mg with that of placebo in maintaining healing of EE
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 |
|---|---|---|---|
| U1111-1113-9433 | REGISTRY | WHO | None |
| 2006-000419-90 | EUDRACT_NUMBER | None | None |