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Completed

NCT Number: NCT05871398

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

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.

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Key information

Conditions

Laryngopharyngeal Reflux Disease

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pusan National University Hospital

Pusan, 49241, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tegoprazan

Drug

Novel, potent, and highly selective potassium-competitive acid blocker which was developed in Korea

Placebo

Drug

Placebo

Primary outcomes

  1. Reflux symptom index (RSI)

    Time frame: 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%.

  2. Reflux finding score (RFS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study title

The Efficacy of Potassium-competitive Acid Blocker (P-CAB) in Patients With Laryngopharyngeal Reflux Disease: a Double- Blind, Randomized, Placebo-controlled Pilot Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
May 23, 2023
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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