Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive reflux disease(NERD)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Esomeprazole

Criteria

Inclusion Criteria:

• subjects who signed written informed consent form

• more than 20 yr subject

• subjects who agree the use of medically accepted birth control during trial

• grade N, M by EGD test

• subject who experience 2 day out of 1 week during recent 1 month

• subject who experience 2 day out of 1 week during run-in period

Exclusion Criteria:

• subjects who can write the diary by himself, herself

• pregnant woman, breastfeeding woman

• allgeric or intolerabiliy to revaprazan or esomeprazole

• feeling of heavy stomach, distention

• surgery history in stomach or esophagus

• active medical history of stomach, esophagus area

• other system disorder which can disturb this trial

• Hep B, C virus, HIV carrier or patients

• past history of malignant tumor

• any psychiatric past or current history

• abnormal lab test

• abnormal ecg test

• zollinger-ellison disease

• current or past history of substance, drug abuse

• subject who should regulary takes medication which can disturb this trial