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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Non-erosive Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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YH1885L 33.3 mg

TID, Subject takes it for 4 week.

Group Type EXPERIMENTAL

YH1885L(Revaprazan)

Intervention Type DRUG

YH1885L 50mg

BID, Subject takes it for 4 week.

Group Type EXPERIMENTAL

YH1885L(Revaprazan)

Intervention Type DRUG

placebo

Intervention Type DRUG

YH1885L 66.6 mg

TID, Subject takes it for 4 week.

Group Type EXPERIMENTAL

YH1885L(Revaprazan)

Intervention Type DRUG

YH1885L 100mg

BID, Subject takes it for 4 week.

Group Type EXPERIMENTAL

YH1885L(Revaprazan)

Intervention Type DRUG

placebo

Intervention Type DRUG

Esomeprazole 20mg

QD, Subject takes it for 4 week.

Group Type ACTIVE_COMPARATOR

Esomeprazole 20mg

Intervention Type DRUG

placebo

Intervention Type DRUG

Interventions

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YH1885L(Revaprazan)

Intervention Type DRUG

Esomeprazole 20mg

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No