Clinical trial NCT05871398: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Laryngopharyngeal Reflux Disease
Keywords: : Laryngopharyngeal reflux disease
potassium-competitive acid blocker
treatment effectiveness
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reflux symptom index (RSI)
timeFrame: Week 8
measure: Reflux finding score (RFS)
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
References:
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.
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.