Efficacy study of additional administration of ilaprazole on patients with burning mouth syndrome caused by laryngopharyngeal reflux disease

Not Applicable

• Conditions: Diseases of th respiratory system

• Registration Number: KCT0004329
• Lead Sponsor: Hallym University Medical Center-Kangnam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 November 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

(1) Patients over 18 year
(2) Laryngopharyngeal reflux disease patients who have RSI more than 13 and RFS more than 7
(3) Patients with suspected burning mouth syndrome caused by laryngopharyngeal reflux disease

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 non-steroidal anti-inflammatory drugs including aspirin (more than 325mg/d), warfarin, coumarin during this clinical trial constantly
(4) Those with observed a symptoms of vitamin B12 deficiency
(5) Those who has undergone clonazepam therapy, hormone therapy, topical capsaicin treatment, topical lidocaine treatment, antidepressant, a-lipoic acid therapy
(6) Those who has undergone surgery or treatment for gastroesophageal reflux disease
(7) Those who has undergone gastric acid suppression surgery or gastro-duodenal surgery
(8) Those who has undergone major surgery affecting gastric acid secretion except surgery such as appendectomy, cholecystectomy, hysterectomy
(9) Psychiatric patient, alcohol addictor or those with the history of drug abuse
(10) Pregnant and lactating women
(11) Childbearing women (Menopausal women who are amenorrheic for at least 12 months are considered to be non-childbearing women.)
(12) Those who participated in other clinical trial within 30 days before screening
(13) Those who use another inhaler
(14) Those with observed preneoplastic lesions or neoplastic lesions in pharynx or larynx
(15) 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
Visual analogue scale;Reflux symptom index (RSI)

Secondary Outcome Measures

Name	Time	Method
Reflux finding score (RFS)