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

July 8, 2014 updated by: Yuhan Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the rate of subject who had 'complete recovery' of symptom after 4 week administration
Time Frame: 4 week
'complete recovery' means subjects never experience heartburn or acid regurgitation during last 1 week.
4 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the rate of subject who had 'appropriate recovery' of symptom after 4 week administration
Time Frame: 4 week
'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
Time Frame: 3 week
3 week
the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion
Time Frame: 3 week
3 week
the number of night symptom-free day after IP administration
Time Frame: 1 week, 2 week, 3 week, 4 week
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
Time Frame: 1 week, 2 week, 3 week, 4 week
1 week, 2 week, 3 week, 4 week
Evalution of Clinical Global Impression of Change
Time Frame: 4 week
4 week
Evaluation of Patient Global Impression of Change
Time Frame: 4 week
4 week
the change of SF-36 Survey score between baseline and completion visit
Time Frame: 4 week
4 week
the change of ESS survey score among baseline, 2 week and 4 week
Time Frame: 2, 4 week
ESS stands for Epworth sleepiness scale.
2, 4 week
Safety
Time Frame: 4 week
AE, Physical exam, 12-lead ECG, Vital signs, laboratory test
4 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Comparison of H.pylori(+),(-) subjects about primay and seconday outcome
Time Frame: 4 week
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuhan Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YH1885L-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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