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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000705

Enrollment

150

Registered

2013-03-18

Start date

2013-02-08

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : Treatment Group investigator product combination Group Days before after after breakfast lunch dinner YH1885L 33.3mg, TID(P.O) 28 ?

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
The rate of subject who had 'complete recovery' of symptom after 4 week administration .	—

Secondary

Measure	Time frame
The rate of subject who had 'appropriate recovery' of symptom after 4 week administration;The rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion ;The rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion;The number of night symptom-free day after IP administration ;The rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score ;Evalution of Clinical Global Impression of Change ;Evaluation of Patient Global Impression of Change;The change of SF-36 Survey score between baseline and completion visit ;The change of ESS survey score among baseline, 2 week and 4 week	—

Measure

Time frame

The rate of subject who had 'appropriate recovery' of symptom after 4 week administration;The rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion ;The rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion;The number of night symptom-free day after IP administration ;The rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score ;Evalution of Clinical Global Impression of Change ;Evaluation of Patient Global Impression of Change;The change of SF-36 Survey score between baseline and completion visit ;The change of ESS survey score among baseline, 2 week and 4 week

—

Countries

Korea, Republic of

Contacts

Public Contactminhee choi

The Catholic University of Korea, Yeouido St. Mary's Hospital

Outcome results