Overview

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