Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02743949
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2016-04-14
Brief Title:
Comparison of Vonoprazan to Esomeprazole in Participants With Symptomatic GERD Who Responded Partially to a High Dose of Proton Pump Inhibitor PPI
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-Blind Proof-of-Concept Phase 2 Study to Evaluate the Efficacy and Safety of Once Daily Oral Vonoprazan 20 mg or Vonoprazan 40 mg Compared to Esomeprazole 40 mg for the Treatment of Subjects With Symptomatic Gastro-Esophageal Reflux Disease Who Have a Partial Response Following Treatment With a High Dose of Proton Pump Inhibitor
Status:
COMPLETED
Status Verified Date:
2020-02
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 determine the effect of vonoprazan compared to esomeprazole for preventing heartburn symptoms over a 4-week treatment period in participants who have a partial response to treatment with esomeprazole
Detailed Description:
The drug being tested in this study is called vonoprazan Vonoprazan is being tested to treat people who have symptomatic gastroesophageal reflux disease GERD with a partial response to treatment with a high dose of esomeprazole This study will look at improvement in heartburn symptoms in participants who take vonoprazan compared to esomeprazole
The study will enroll approximately 213 patients All participants will receive esomeprazole or esomeprazole placebo-matching capsules this is a capsule that looks like esomeprazole but has no active ingredient during a 7-week run-in period Participants will then be randomly assigned by chance like flipping a coin to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
Esomeprazole 40 mg
Vonoprazan 20 mg
Vonoprazan 40 mg
All participants will be asked to take one capsule at the same time each day throughout the study All participants will be asked to record heartburn symptoms in a diary every morning upon waking and every evening before going to sleep
This multi-center trial will be conducted in Europe The overall time to participate in this study is 12 weeks Participants will make multiple visits to the clinic and will be contacted by telephone 1 week after the last dose of study drug for a follow-up assessment
The study will enroll approximately 213 patients All participants will receive esomeprazole or esomeprazole placebo-matching capsules this is a capsule that looks like esomeprazole but has no active ingredient during a 7-week run-in period Participants will then be randomly assigned by chance like flipping a coin to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
Esomeprazole 40 mg
Vonoprazan 20 mg
Vonoprazan 40 mg
All participants will be asked to take one capsule at the same time each day throughout the study All participants will be asked to record heartburn symptoms in a diary every morning upon waking and every evening before going to sleep
This multi-center trial will be conducted in Europe The overall time to participate in this study is 12 weeks Participants will make multiple visits to the clinic and will be contacted by telephone 1 week after the last dose of study drug for a follow-up assessment
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 |
|---|---|---|---|
| 16LO0285 | REGISTRY | NRES | None |
| U1111-1172-2373 | REGISTRY | None | None |
| 2015-001154-14 | EUDRACT_NUMBER | None | None |