Short-term efficacy of tegoprazan in patients with non-erosive reflux disease with nocturnal heartburn symptom

Short-term efficacy of K-CAB 50 mg (tegoprazan) compared with Nexium 20 mg (esomeprazole magnesium) in patients with non-erosive reflux disease with nocturnal heartburn symptom

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004833

Enrollment

160

Registered

2020-03-16

Start date

2020-03-02

Completion date

Unknown

Last updated

2020-03-23

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

Conditions

None listed

Interventions

Drug : 1.Tegoprazan 50mg, once a day, administered orally, HS 2.Esomeprazole 20mg, once a day, administered orally, HS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Only adult men and women over 19 years old 2) Those who have complained of heartburn at least 6 months prior to Visit 1 3) No mucosal break was observed according to LA classification in the upper gastrointestinal endoscopy performed by the institution within 28 days before the start of investigational drug administration. 4) Those who have a GERD-Q questionnaire score of 8 or higher in the screening test 5) Those who complain of nighttime heartburn more than 3 times a week

Exclusion criteria

Exclusion criteria: 1) Those who cannot receive an upper gastrointestinal endoscopy 2) Upper gastrointestinal endoscopy shows esophageal stricture, gastrointestinal varices, Barrett's esophagus, active peptic ucler, GI bleeding, or eosinophilic esophagitis 3) Those who received surgery on esophagus, stomach or duodenum 4) Those who have hypersensitivity reactions to medicines for clinical trials 5) Pregnant women, lactating women

Design outcomes

Primary

Measure	Time frame
Percentage of days without nocturnal heartburn symptom	—

Secondary

Measure	Time frame
Percentage of subjects whose nocturnal heartburn symptoms are subsided	—

Countries

Korea, Republic of

Contacts

Public ContactJin Lee

Inje University Haeundae Paik Hospital

Outcome results