Efficacy of ilaprazole in contact granuloma: the comparison between different dose and administration period

The comparative study of efficacy between different ilaprazole dose and administration period on contact granuloma caused by laryngopharyngeal reflux

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005038

Enrollment

288

Registered

2020-05-19

Start date

2020-08-03

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

None listed

Interventions

Drug : The subjects with contact granuloma associated laryngopharyngeal reflux (LPR) will be randomized at the ratio of 1:1:1:1 into one of the following 4 arms: ilaprazole 10mg once daily for 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Diameter of contact granuloma	—

Secondary

Measure	Time frame
Reflux symptom index (RSI);Reflux finding score (RFS)	—

Countries

Korea, Republic of

Contacts

Public ContactBonseok Koo

Chungnam National University Hospital

bskoo515@gmail.com+82-42-280-7690

Outcome results