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

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)

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 Overview

• Status: Completed
• Conditions: Non-erosive Reflux Disease
• Intervention / Treatment: Drug: placebo; Drug: YH1885L(Revaprazan); Drug: Esomeprazole 20mg

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • DongA University Hospital
  • Daegu, Korea, Republic of
    • Kyungbook University hospital
  • Daejeon, Korea, Republic of
    • Chungnam University Hospital
  • Incheon, Korea, Republic of
    • Catholic Incheon hospital
  • Jeonju, Korea, Republic of
    • Jeonbuk University Hospital
  • Seoul, Korea, Republic of
    • Asan hospital
  • Seoul, Korea, Republic of
    • Kyunghee University Hospital
  • Seoul, Korea, Republic of
    • Seoul university hospital
  • Seoul, Korea, Republic of
    • Catholic Yeouido Sungmo Hospital
  • Seoul, Korea, Republic of
    • Konkuk unversity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YH1885L 33.3 mg; TID, Subject takes it for 4 week.	Drug: YH1885L(Revaprazan)
Experimental: YH1885L 50mg; BID, Subject takes it for 4 week.	Drug: placebo; Drug: YH1885L(Revaprazan)
Experimental: YH1885L 66.6 mg; TID, Subject takes it for 4 week.	Drug: YH1885L(Revaprazan)
Experimental: YH1885L 100mg; BID, Subject takes it for 4 week.	Drug: placebo; Drug: YH1885L(Revaprazan)
Active Comparator: Esomeprazole 20mg; QD, Subject takes it for 4 week.	Drug: placebo; Drug: Esomeprazole 20mg; Other Names: Nexium

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Comparison of H.pylori(+),(-) subjects about primay and seconday outcome	4 week

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 8, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: NERD
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: YH1885L-201