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

Last updated: May 29, 2023
Sponsor: Pusan National University Hospital
Overall Status: Completed

Phase

3

Condition

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Treatment

Placebo

Tegoprazan

Clinical Study ID

NCT05871398
H-1909-005-096
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • At least one symptom of LPRD (hoarseness, globus, persistent throat discomfort, andfrequent throat clearing) for at least 4 weeks
  • Reflux symptom index > 13 and reflux finding score ≥ 7

Exclusion

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 beforescreening), histamine receptor 2 blockers, antacids or prokinetics (within 2 weeksbefore screening)
  • Need for continuous therapy with non-steroidal anti-inflammatory drugs
  • Pregnant or breastfeeding women, as well as female patients who were not willing touse contraception for the duration of the clinical trial period
  • Abnormal laboratory test values at screening (blood urea nitrogen and serum creatinelevel >1.5 upper limit of normal [ULN]; total bilirubin levels and serum levels ofalanine aminotransferase, aspartate aminotransferase, alkaline phosphatase andgamma-glutamyl transferase > 2 ULN) or
  • Any other conditions or disease that an investigator considered not appropriate forthis study

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 01, 2019
Estimated Completion Date:
February 28, 2023

Connect with a study center

  • Pusan National University Hospital

    Pusan, 49241
    Korea, Republic of

    Site Not Available

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