A comparative study of efficacy of ilaprazole according to the body mass index in patients with laryngopharyngeal reflux disease

Not Applicable

Completed

• Conditions: Diseases of the respiratory system

• Registration Number: KCT0004035
• Lead Sponsor: Hallym University Medical Center-Kangnam

Brief Summary

When Noltek was used for 4 weeks and 12 weeks, the degree of RSI improvement was significantly improved compared to Initial, and it was more significantly improved when used for 12 weeks than when used for 4 weeks. The degree of RSI improvement showed an effect of improving RSI compared to initial at 4 weeks and 12 weeks in all 3 groups without a significant difference according to BMI when BMI was divided into 3 groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-07-30
• Last Update Posted: 10 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

(1) Men or women above 18 years of age and having symptoms of laryngopharyngeal reflux disease that has lasted more than a month
(2) Those with above 13 and 7 score in reflux symptom index (RSI) and reflux finding score (RFS) of laryngopharyngeal reflux disease
(3) Those who heard the explanation of this clinical trial and decide to participate voluntarily and sign the consent form

Exclusion Criteria

(1) The highly sensitive person to proton pump inhibitor including ilaprazole
(2) Those with the history of malignant tumor of the larynx
(3) Those with need to take steroids or aspirin(more than 325mg/d), warfarin, coumarin during this study constantly
(4) Those who has undergone surgery or treatment for gastroesophageal reflux disease or gastric acid suppression surgery or gastro-duodenal surgery
(5) Those who has undergone major surgery affecting gastric acid secretion
(6) Psychiatric patient, alcohol addictor or those with the history of drug abuse
(7) Pregnant and lactating women
(8) Childbearing women (Menopausal women who are amenorrheic for at least 12 months are considered to be non-childbearing women.)
(9) Those who participated in other clinical trial within 6 months before screening
(10) Those with observed preneoplastic lesions or neoplastic lesions in pharynx or larynx
(11) Those who are judged to be improper for this clinical trial

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reflux finding score (RFS)

Secondary Outcome Measures

Name	Time	Method
Reflux symptom index (RSI)