Efficacy of ilaprazole in contact granuloma: the comparison between different dose and administration period
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0005038
- Lead Sponsor
- Chungnam National University Hospital
- Brief Summary
There were significant dose- and duration-dependent differences in the efficacy of ilaprazole in patients with contact granuloma due to oropharyngeal reflux.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 288
1) Patients over 19 year and below 75 year
2) Those who have reflux symptom index (RSI) more than 13 and reflux finding score (RFS) more than 7
3) Those with contact granuloma according to results of laryngoscope
4) Those who agree to participate in this clinical trial and sign voluntarily
5) Those who don’t have dementia or cognitive impairment
1) Those with the history of hypersensitivity reaction to proton pump inhibitor including ilaprazole
2) Those with need to take steroids or warfarin, coumarin, aspirin (more than 325mg/d) during this clinical trial constantly
3) Those with the history of administration with H2 receptor antagonists (H2RA), prostaglandin, protective agent of gastric mucosa, prokinetics, antiplatelet, and anticoagulants within 2 weeks or proton pump inhibitor (PPI) within 4 weeks from investigational drug administration
4) Those with the history of malignant tumor or surgery of the larynx
5) Those with observed preneoplastic lesions or neoplastic lesions in pharynx or larynx
6) Patients with zollinger-ellison syndrome, 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 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 Diameter of contact granuloma
- Secondary Outcome Measures
Name Time Method Reflux symptom index (RSI);Reflux finding score (RFS)