Laryngopharyngeal Reflux Disease
Conditions
Keywords
: Laryngopharyngeal reflux disease, potassium-competitive acid blocker, treatment effectiveness
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.
Interventions
DRUGTegoprazan
Novel, potent, and highly selective potassium-competitive acid blocker which was developed in Korea
DRUGPlacebo
Placebo
Sponsors
Pusan National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reflux symptom index (RSI) | Week 8 | 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) | Week 8 | 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. |
Countries
South Korea
Outcome results
None listed