Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05871398
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2023-05-02
Brief Title:
The Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease
Sponsor:
Pusan National University Hospital
Organization:
Pusan National University Hospital
Study Overview
Official Title:
The Efficacy of Potassium-competitive Acid Blocker P-CAB in Patients With Laryngopharyngeal Reflux Disease a Double- Blind Randomized Placebo-controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-05
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:
BackgroundAims Tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period which could offer clinical benefit in acid-related disorders The investigators aimed to evaluate whether tegoprazan would be more effective in controlling symptoms than placebo in patients with laryngopharyngeal reflux disease LPRD Methods This double-blind randomized placebo-controlled trial randomly assigned 35 patients suffering LPRD symptom to two groups Tegoprazan50mg once daily and placebo The primary end point was complete resolution rate of LPRD symptoms after 8-week medication and the secondary endpoints were complete resolution rate of LPRD symptoms after 4-week medication change of reflux symptom index RSI and reflux finding score RFS from baseline at 4- and 8-week medication
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None