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

Phase 2

Completed

• Conditions: Non-erosive Reflux Disease
• Interventions: Drug: YH1885L(Revaprazan); Drug: Esomeprazole 20mg; Drug: placebo

• Registration Number: NCT01750437
• Lead Sponsor: Yuhan Corporation

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Study Start: 2013-01
• Primary Completion: 2013-10
• Study Completion: 2014-04
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YH1885L 33.3 mg	YH1885L(Revaprazan)	TID, Subject takes it for 4 week.
YH1885L 50mg	placebo	BID, Subject takes it for 4 week.
YH1885L 100mg	YH1885L(Revaprazan)	BID, Subject takes it for 4 week.
YH1885L 100mg	placebo	BID, Subject takes it for 4 week.
Esomeprazole 20mg	placebo	QD, Subject takes it for 4 week.
Esomeprazole 20mg	Esomeprazole 20mg	QD, Subject takes it for 4 week.
YH1885L 50mg	YH1885L(Revaprazan)	BID, Subject takes it for 4 week.
YH1885L 66.6 mg	YH1885L(Revaprazan)	TID, Subject takes it for 4 week.

Primary Outcome Measures

Name	Time	Method
the rate of subject who had 'complete recovery' of symptom after 4 week administration	4 week	'complete recovery' means subjects never experience heartburn or acid regurgitation during last 1 week.

Secondary Outcome Measures

Name	Time	Method
the rate of subject who had 'appropriate recovery' of symptom after 4 week administration	4 week	'Appropriate recovery' means subjects experience heartburn or acid regurgitation only 1 or less during last 1 week.
the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion	3 week
the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion	3 week
the change of ESS survey score among baseline, 2 week and 4 week	2, 4 week	ESS stands for Epworth sleepiness scale.
the rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score	1 week, 2 week, 3 week, 4 week
Safety	4 week	AE, Physical exam, 12-lead ECG, Vital signs, laboratory test
the change of SF-36 Survey score between baseline and completion visit	4 week
the number of night symptom-free day after IP administration	1 week, 2 week, 3 week, 4 week	Symptoms means "Heartburn or Acid regurgitation"
Evalution of Clinical Global Impression of Change	4 week
Evaluation of Patient Global Impression of Change	4 week

Trial Locations

Locations (10)

DongA university hospital; 🇰🇷 Busan, Korea, Republic of

Kyungbook University hospital; 🇰🇷 Daegu, Korea, Republic of

Chungnam university hospital; 🇰🇷 Daejeon, Korea, Republic of

Catholic Incheon hospital; 🇰🇷 Incheon, Korea, Republic of

Jeonbuk University hospital; 🇰🇷 Jeonju, Korea, Republic of

Asan hospital; 🇰🇷 Seoul, Korea, Republic of

Catholic yeouido sungmo hospital; 🇰🇷 Seoul, Korea, Republic of

Konkuk unversity hospital; 🇰🇷 Seoul, Korea, Republic of

Kyunghee university hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul university hospital; 🇰🇷 Seoul, Korea, Republic of