The Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease

Pusan National University

Status and phase: Completed; Phase 3

Conditions: Laryngopharyngeal Reflux Disease

Treatments: Drug: Placebo; Drug: Tegoprazan

Study type: Interventional

Funder types: Other

Identifiers

NCT05871398

H-1909-005-096

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

36 participants in 2 patient groups, including a placebo group

placebo group

Placebo Comparator group

Treatment:

Drug: Placebo

tegoprazan group

Active Comparator group

Treatment:

Drug: Tegoprazan