Clinical trial NCT01750437: Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-erosive Reflux Disease
Keywords: NERD
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 149
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility 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

Primary outcomes:
measure: the rate of subject who had 'complete recovery' of symptom after 4 week administration
timeFrame: 4 week
Secondary outcomes:
measure: the rate of subject who had 'appropriate recovery' of symptom after 4 week administration
timeFrame: 4 week
measure: the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion
timeFrame: 3 week
measure: the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion
timeFrame: 3 week
measure: the number of night symptom-free day after IP administration
timeFrame: 1 week, 2 week, 3 week, 4 week
measure: the rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score
timeFrame: 1 week, 2 week, 3 week, 4 week
measure: Evalution of Clinical Global Impression of Change
timeFrame: 4 week
measure: Evaluation of Patient Global Impression of Change
timeFrame: 4 week
measure: the change of SF-36 Survey score between baseline and completion visit
timeFrame: 4 week
measure: the change of ESS survey score among baseline, 2 week and 4 week
timeFrame: 2, 4 week
measure: Safety
timeFrame: 4 week
Other outcomes:
measure: Comparison of H.pylori(+),(-) subjects about primay and seconday outcome
timeFrame: 4 week
Locations:
city: Busan
country: Korea, Republic of
facility: DongA university hospital
city: Daegu
country: Korea, Republic of
facility: Kyungbook University hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam university hospital
city: Incheon
country: Korea, Republic of
facility: Catholic Incheon hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk University hospital
city: Seoul
country: Korea, Republic of
facility: Asan hospital
city: Seoul
country: Korea, Republic of
facility: Catholic yeouido sungmo hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk unversity hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee university hospital
city: Seoul
country: Korea, Republic of
facility: Seoul university hospital
Study officials:
References: