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

Yuhan

Status and phase: Completed; Phase 2

Conditions: Non-erosive Reflux Disease

Treatments: Drug: YH1885L(Revaprazan); Drug: Esomeprazole 20mg; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01750437

YH1885L-201

Details and patient eligibility

About

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)

Enrollment: 149 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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149 participants in 5 patient groups

YH1885L 33.3 mg

Experimental group

Description:

TID, Subject takes it for 4 week.

Treatment:

Drug: YH1885L(Revaprazan)

YH1885L 50mg

Experimental group

Description:

BID, Subject takes it for 4 week.

Treatment:

Drug: YH1885L(Revaprazan)

Drug: placebo

YH1885L 66.6 mg

Experimental group

Description:

TID, Subject takes it for 4 week.

Treatment:

Drug: YH1885L(Revaprazan)

YH1885L 100mg

Experimental group

Description:

BID, Subject takes it for 4 week.

Treatment:

Drug: YH1885L(Revaprazan)

Drug: placebo

Esomeprazole 20mg

Active Comparator group

Description:

QD, Subject takes it for 4 week.

Treatment:

Drug: Esomeprazole 20mg

Drug: placebo