Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02162758
Status:
TERMINATED
Last Update Posted:
2017-05-11
First Post:
2014-06-10
Brief Title:
Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barretts Esophagus With Radiofrequency Ablation
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-Blind Phase 4 Study to Evaluate the Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barretts Esophagus With Radiofrequency Ablation
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Decisions No Safety Concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to evaluate the effect of dexlansoprazole once daily QD and twice daily BID dosing on the recurrence of intestinal metaplasia IM in participants who achieved complete eradication of Barretts esophagus BE with high-grade dysplasia HGD following radiofrequency ablation RFA
Detailed Description:
The drug being tested in this study is called dexlansoprazole The purpose of this study is to evaluate the effect of 12 months of treatment with dexlansoprazole 60 mg QD or dexlansoprazole 60 mg BID on the recurrence of IM in participants who have achieved complete eradication of intestinal metaplasia CEIM and dysplasia CED with RFA The study will enroll approximately 150 participants Participants will be randomly assigned by chance like flipping a coin to one of the two treatment groups which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
Dexlansoprazole 60 mg once a day and placebo this is a capsule that looks like the study drug but has no active ingredient once a day
Dexlansoprazole 60 mg twice a day
All participants will be asked to take one capsule twice a day at the same time each day throughout the study
This randomized double-blind multi-center parallel group trial will be conducted in North America The overall time to participate in this study is up to 13 months Participants will make 5 visits to the clinic and will undergo a safety follow-up assessment 30 days after the last dose of study drug
Dexlansoprazole 60 mg once a day and placebo this is a capsule that looks like the study drug but has no active ingredient once a day
Dexlansoprazole 60 mg twice a day
All participants will be asked to take one capsule twice a day at the same time each day throughout the study
This randomized double-blind multi-center parallel group trial will be conducted in North America The overall time to participate in this study is up to 13 months Participants will make 5 visits to the clinic and will undergo a safety follow-up assessment 30 days after the last dose of study drug
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 |
|---|---|---|---|
| U1111-1152-6767 | REGISTRY | WHO | None |