Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251745
Status:
COMPLETED
Last Update Posted:
2011-04-28
First Post:
2005-11-08
Brief Title:
Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR 60 mg Once-Daily QD and 90 mg QD Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive 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 daily treatment with Dexlansoprazole modified release MR 60 mg or 90 mg once daily QD compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with 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 daily Dexlansoprazole MR 60 mg and 90 mg 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 non-erosive GERD Approximately 450 subjects will be enrolled at approximately 120 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
Because the development plan for Dexlansoprazole MR was revised the results of 2 identical studies T-GD04-082 this posting NCT00241745 and T-GD04-083 NCT00251758 were combined and analyzed as a single larger study referred to as study T-GD04-082 A total of 908 subjects were included in the combined analysis 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083
Because the development plan for Dexlansoprazole MR was revised the results of 2 identical studies T-GD04-082 this posting NCT00241745 and T-GD04-083 NCT00251758 were combined and analyzed as a single larger study referred to as study T-GD04-082 A total of 908 subjects were included in the combined analysis 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083
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 |
|---|---|---|---|
| U1111-1114-0144 | REGISTRY | WHO | None |