A study on the efficacy of treatment of Dry mouth syndrome accompanied by Laryngopharyngeal Reflux Disease with or without additional Ilaprazole administration

A comparative study on the improvement of Dry mouth syndrome and Laryngopharyngeal reflux disease according to the administration of Ilaprazole in patient with Laryngopharyngeal reflux disease and dry mouth

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003888

Enrollment

172

Registered

2019-05-07

Start date

2019-05-31

Completion date

Unknown

Last updated

2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : After administration of Pilocarpine alone or Pilocarpine and Ilaprazole together, the effect of those therapies on improvement of Xerostomia would be evaluated.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Men or Women between the ages of 18 and 80 (2) Patients having dry mouth and symptoms of Laryngopharyngeal reflux disease observed by Laryngoscope and with the chronic symptoms such as globus pharyngis, heartburn, voice change, pain, hoarseness, dysphagia, cough (3) Those who heard the explanation of this clinical trial and decided to voluntarily participate and signed the consent form

Exclusion criteria

Exclusion criteria: Those with hypersensitivity to Proton pump inhibitor including Ilaprazole (2) Those with the history of malignant tumor of the larynx (3) Those with the history of Head and Neck radiation therapy and diagnosed with Sjogren’s Syndrome (4) Those with need to constantly take Steroids or Non steroidal anti inflammatory drugs including Aspirin (more than 325mg/d), Warfarin, Coumarin. (5) Those who took Prokinetics, Steroids 7 days before evaluation of saliva secretion. (6) Those who used chemical compound inhaler (7) Those who has undergone surgery or treatment for Gastroesophageal reflux disease. (8) Those who has undergone gastric acid suppression surgery or gastro-duodenal surgery. (9) Those who has undergone major surgery affecting gastric acid secretion except surgery such as appendectomy, cholecystectomy, hysterectomy. (10) Current Zollinger-Ellison Syndrome patient and alcohol addictor or those with the history of drug abuse. (11) Pregnant and lactating women (12) Childbearing women (Menopausal women who are amenorrheic for at least 12 months are considered to be non-childbearing women) (13) Those who participated in other clinical trial within 30 days before Screening. (14) Those who are judged to be improper for this clinical trial.

Design outcomes

Primary

Measure	Time frame
Questionnaire on dry mouth;Volume and rate of Saliva Secretion	—

Secondary

Measure	Time frame
Reflux Symptom Index;Reflux Finding SAcore	—

Countries

Korea, Republic of

Contacts

Public ContactJi Won Kim

Asan Medical Center

hopefuljw@gamil.com+82-32-890-2424

Outcome results