Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321984
Status:
COMPLETED
Last Update Posted:
2011-04-28
First Post:
2006-05-02
Brief Title:
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR 30 mg QD and 60 mg QD Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease GERD
Status:
COMPLETED
Status Verified Date:
2011-04
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 Dexlansoprazole modified release MR 30 mg once daily QD or 60 mg QD compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic nonerosive gastroesophageal reflux disease GERD
Detailed Description:
This is a Phase 3 randomized double-blind multicenter placebo-controlled 3-arm study with a 4 week treatment period This study will compare the efficacy of Dexlansoprazole MR 30 mg QD and 60 mg QD with that of placebo when administered orally as a single daily dose in the morning before breakfast The study is designed to evaluate symptom relief in subjects with symptomatic nonerosive GERD Approximately 900 subjects will be enrolled at approximately 200 United States US and potentially ex-US sites The study consists of two periods a screening period which will last a minimum of 7 days and a maximum of 21 days and a treatment period which will last 4 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 |
|---|---|---|---|
| U1111-1114-1935 | REGISTRY | WHO | None |
| 2006-000420-13 | EUDRACT_NUMBER | None | None |