Back to resultsThe Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease
Primary Purpose
Laryngopharyngeal Reflux Disease
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tegoprazan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Laryngopharyngeal Reflux Disease focused on measuring : Laryngopharyngeal reflux disease, potassium-competitive acid blocker, treatment effectiveness
Eligibility Criteria
Inclusion Criteria: At least one symptom of LPRD (hoarseness, globus, persistent throat discomfort, and frequent throat clearing) for at least 4 weeks Reflux symptom index > 13 and reflux finding score ≥ 7 Exclusion Criteria: Viral or bacterial laryngopharyngitis at present History of malignancy of head and neck region, esophagus and stomach Previous radiotherapy or endotracheal intubation within three months Previous anti-reflux surgery or gastroesophageal surgery Diagnosis of depression, anxiety, panic, somatoform or other psychotic disorder Taking anti-psychotics, anti-depressants or anti-anxiety drugs Anti-reflux medication such as proton-pump inhibitors (within 4 weeks before screening), histamine receptor 2 blockers, antacids or prokinetics (within 2 weeks before screening) Need for continuous therapy with non-steroidal anti-inflammatory drugs Pregnant or breastfeeding women, as well as female patients who were not willing to use contraception for the duration of the clinical trial period Abnormal laboratory test values at screening (blood urea nitrogen and serum creatine level >1.5 upper limit of normal [ULN]; total bilirubin levels and serum levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and gamma-glutamyl transferase > 2 ULN) or Any other conditions or disease that an investigator considered not appropriate for this study
Sites / Locations
- Pusan National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo group
tegoprazan group
Arm Description
Outcomes
Primary Outcome Measures
Reflux symptom index (RSI)
RSI is a validated nine-item, self-administered questionnaire to assess the severity and responses to treatment of laryngopharyngeal reflux disease-associated symptoms. Each component is scored between 0 (no problem) and 5 (severe problem), with a maximum total score of 45.
Non-response = RSI ≥ 13, Response = post-treatment RSI < 13 and change in RSI < 50%, Complete response = post-treatment RSI < 13 and change in RSI ≥ 50%.
Reflux finding score (RFS)
RFS is a validated rating scale developed to quantify the degree of laryngeal involvement in laryngopharyngeal reflux disease during fiberoptic laryngoscopy. Scores range from 0 (no abnormal findings) to 26 (worst score possible).
Normal < 7, Abnormal ≥ 7.
Secondary Outcome Measures
Full Information
NCT ID
NCT05871398
First Posted
May 2, 2023
Last Updated
May 29, 2023
Sponsor
Pusan National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05871398
Brief Title
The Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pusan National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Background/Aims: 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngopharyngeal Reflux Disease
Keywords
: Laryngopharyngeal reflux disease, potassium-competitive acid blocker, treatment effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Title
tegoprazan group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tegoprazan
Intervention Description
Novel, potent, and highly selective potassium-competitive acid blocker which was developed in Korea
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Reflux symptom index (RSI)
Description
RSI is a validated nine-item, self-administered questionnaire to assess the severity and responses to treatment of laryngopharyngeal reflux disease-associated symptoms. Each component is scored between 0 (no problem) and 5 (severe problem), with a maximum total score of 45.
Non-response = RSI ≥ 13, Response = post-treatment RSI < 13 and change in RSI < 50%, Complete response = post-treatment RSI < 13 and change in RSI ≥ 50%.
Time Frame
Week 8
Title
Reflux finding score (RFS)
Description
RFS is a validated rating scale developed to quantify the degree of laryngeal involvement in laryngopharyngeal reflux disease during fiberoptic laryngoscopy. Scores range from 0 (no abnormal findings) to 26 (worst score possible).
Normal < 7, Abnormal ≥ 7.
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least one symptom of LPRD (hoarseness, globus, persistent throat discomfort, and frequent throat clearing) for at least 4 weeks
Reflux symptom index > 13 and reflux finding score ≥ 7
Exclusion Criteria:
Viral or bacterial laryngopharyngitis at present
History of malignancy of head and neck region, esophagus and stomach
Previous radiotherapy or endotracheal intubation within three months
Previous anti-reflux surgery or gastroesophageal surgery
Diagnosis of depression, anxiety, panic, somatoform or other psychotic disorder
Taking anti-psychotics, anti-depressants or anti-anxiety drugs
Anti-reflux medication such as proton-pump inhibitors (within 4 weeks before screening), histamine receptor 2 blockers, antacids or prokinetics (within 2 weeks before screening)
Need for continuous therapy with non-steroidal anti-inflammatory drugs
Pregnant or breastfeeding women, as well as female patients who were not willing to use contraception for the duration of the clinical trial period
Abnormal laboratory test values at screening (blood urea nitrogen and serum creatine level >1.5 upper limit of normal [ULN]; total bilirubin levels and serum levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and gamma-glutamyl transferase > 2 ULN) or
Any other conditions or disease that an investigator considered not appropriate for this study
Facility Information:
Facility Name
Pusan National University Hospital
City
Pusan
ZIP/Postal Code
49241
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30234664
Citation
Lechien JR, Saussez S, Karkos PD. Laryngopharyngeal reflux disease: clinical presentation, diagnosis and therapeutic challenges in 2018. Curr Opin Otolaryngol Head Neck Surg. 2018 Dec;26(6):392-402. doi: 10.1097/MOO.0000000000000486.
Results Reference
background
PubMed Identifier
33229333
Citation
Katzka DA, Kahrilas PJ. Advances in the diagnosis and management of gastroesophageal reflux disease. BMJ. 2020 Nov 23;371:m3786. doi: 10.1136/bmj.m3786.
Results Reference
background
Learn more about this trial
The Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease
We'll reach out to this number within 24 hrs