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

Primary Purpose

Non-erosive Reflux Disease

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YH1885L(Revaprazan)
Esomeprazole 20mg
placebo
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-erosive Reflux Disease focused on measuring NERD

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • DongA university hospital
  • Kyungbook University hospital
  • Chungnam university hospital
  • Catholic Incheon hospital
  • Jeonbuk University hospital
  • Asan hospital
  • Catholic yeouido sungmo hospital
  • Konkuk unversity hospital
  • Kyunghee university hospital
  • Seoul university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

YH1885L 33.3 mg

YH1885L 50mg

YH1885L 66.6 mg

YH1885L 100mg

Esomeprazole 20mg

Arm Description

TID, Subject takes it for 4 week.

BID, Subject takes it for 4 week.

TID, Subject takes it for 4 week.

BID, Subject takes it for 4 week.

QD, Subject takes it for 4 week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2012
Last Updated
July 8, 2014
Sponsor
Yuhan Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01750437
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-erosive Reflux Disease
Keywords
NERD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YH1885L 33.3 mg
Arm Type
Experimental
Arm Description
TID, Subject takes it for 4 week.
Arm Title
YH1885L 50mg
Arm Type
Experimental
Arm Description
BID, Subject takes it for 4 week.
Arm Title
YH1885L 66.6 mg
Arm Type
Experimental
Arm Description
TID, Subject takes it for 4 week.
Arm Title
YH1885L 100mg
Arm Type
Experimental
Arm Description
BID, Subject takes it for 4 week.
Arm Title
Esomeprazole 20mg
Arm Type
Active Comparator
Arm Description
QD, Subject takes it for 4 week.
Intervention Type
Drug
Intervention Name(s)
YH1885L(Revaprazan)
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 20mg
Other Intervention Name(s)
Nexium
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
the rate of subject who had 'complete recovery' of symptom after 4 week administration
Description
'complete recovery' means subjects never experience heartburn or acid regurgitation during last 1 week.
Time Frame
4 week
Secondary Outcome Measure Information:
Title
the rate of subject who had 'appropriate recovery' of symptom after 4 week administration
Description
'Appropriate recovery' means subjects experience heartburn or acid regurgitation only 1 or less during last 1 week.
Time Frame
4 week
Title
the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion
Time Frame
3 week
Title
the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion
Time Frame
3 week
Title
the number of night symptom-free day after IP administration
Description
Symptoms means "Heartburn or Acid regurgitation"
Time Frame
1 week, 2 week, 3 week, 4 week
Title
the rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score
Time Frame
1 week, 2 week, 3 week, 4 week
Title
Evalution of Clinical Global Impression of Change
Time Frame
4 week
Title
Evaluation of Patient Global Impression of Change
Time Frame
4 week
Title
the change of SF-36 Survey score between baseline and completion visit
Time Frame
4 week
Title
the change of ESS survey score among baseline, 2 week and 4 week
Description
ESS stands for Epworth sleepiness scale.
Time Frame
2, 4 week
Title
Safety
Description
AE, Physical exam, 12-lead ECG, Vital signs, laboratory test
Time Frame
4 week
Other Pre-specified Outcome Measures:
Title
Comparison of H.pylori(+),(-) subjects about primay and seconday outcome
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
DongA university hospital
City
Busan
Country
Korea, Republic of
Facility Name
Kyungbook University hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam university hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Catholic Incheon hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Jeonbuk University hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Asan hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Catholic yeouido sungmo hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk unversity hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyunghee university hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul university hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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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