Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251693
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2005-11-08
Brief Title:
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR 60 mg Once- Daily QD and 90 mg QD and an Active Comparator Lansoprazole 30 mg QD on Healing of 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 efficacy and safety of 8 weeks of once-daily QD treatment with dexlansoprazole modified release MR 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis
Detailed Description:
This is a Phase 3 randomized double-blind multi-center active-controlled 3-arm study with an 8-week treatment period This study will compare the efficacy of dexlansoprazole MR 60 mg QD and 90 mg QD with that of lansoprazole 30 mg when administered orally as a single daily dose in the morning before breakfast The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease-related symptoms The study consists of two periods a screening period maximum 21 days and a treatment period which will last 8 weeks
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 |
|---|---|---|---|
| U1111-1113-9373 | REGISTRY | WHO | None |