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

Purpose

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)

Condition	Intervention	Phase
Non-erosive Reflux Disease	Drug: YH1885L(Revaprazan) Drug: Esomeprazole 20mg Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:

the rate of subject who had 'complete recovery' of symptom after 4 week administration [ Time Frame: 4 week ] [ Designated as safety issue: No ]
'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 [ Time Frame: 4 week ] [ Designated as safety issue: No ]
'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 [ Time Frame: 3 week ] [ Designated as safety issue: No ]
the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion [ Time Frame: 3 week ] [ Designated as safety issue: No ]
the number of night symptom-free day after IP administration [ Time Frame: 1 week, 2 week, 3 week, 4 week ] [ Designated as safety issue: No ]
Symptoms means "Heartburn or Acid regurgitation"
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 ] [ Designated as safety issue: No ]
Evalution of Clinical Global Impression of Change [ Time Frame: 4 week ] [ Designated as safety issue: No ]
Evaluation of Patient Global Impression of Change [ Time Frame: 4 week ] [ Designated as safety issue: No ]
the change of SF-36 Survey score between baseline and completion visit [ Time Frame: 4 week ] [ Designated as safety issue: No ]
the change of ESS survey score among baseline, 2 week and 4 week [ Time Frame: 2, 4 week ] [ Designated as safety issue: No ]
ESS stands for Epworth sleepiness scale.
Safety [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
AE, Physical exam, 12-lead ECG, Vital signs, laboratory test

Other Outcome Measures:

Comparison of H.pylori(+),(-) subjects about primay and seconday outcome [ Time Frame: 4 week ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2013
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: YH1885L(Revaprazan) Drug: placebo
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: YH1885L(Revaprazan) Drug: placebo
Active Comparator: Esomeprazole 20mg QD, Subject takes it for 4 week.	Drug: Esomeprazole 20mg Other Name: Nexium Drug: placebo

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750437

Locations

Korea, Republic of
DongA university hospital	Recruiting
Busan, Korea, Republic of
Contact: Choi, MD, PhD 051-240-5676
Principal Investigator: Choi, PhD, MD
Kyungbook University hospital	Recruiting
Daegu, Korea, Republic of
Contact: Kim, MD, PhD 053-420-5515
Principal Investigator: Kim, PhD, MD
Chungnam university hospital	Recruiting
Daejeon, Korea, Republic of
Contact: Jeong, MD,PhD 042-280-8557
Principal Investigator: Jeong, Ph D, MD
Catholic Incheon hospital	Recruiting
Incheon, Korea, Republic of
Contact: Kim, MD, PhD 032-280-5969
Principal Investigator: Kim, Ph D, MD
Jeonbuk University hospital	Recruiting
Jeonju, Korea, Republic of
Contact: Lee, MD, PhD 063-250-1533
Principal Investigator: Lee, PhD, MD
Asan hospital	Recruiting
Seoul, Korea, Republic of
Contact: Jeong, MD, PhD 02-3010-3180
Principal Investigator: Jeong, PhD, MD
Konkuk unversity hospital	Recruiting
Seoul, Korea, Republic of
Contact: Sung, MD, PhD 02-2030-7747
Principal Investigator: Sung, Ph D, MD
Kyunghee university hospital	Recruiting
Seoul, Korea, Republic of
Contact: Jang, MD, PhD 02-958-8199
Principal Investigator: Jang, PhD, MD
Seoul university hospital	Recruiting
Seoul, Korea, Republic of
Contact: Kim, MD, PhD 02-740-8112
Principal Investigator: Kim, PhD, MD
Catholic yeouido sungmo hospital	Recruiting
Seoul, Korea, Republic of
Contact: Park, PhD 02-3779-1587
Principal Investigator: Park, PhD, MD

Sponsors and Collaborators

Yuhan Corporation

More Information

No publications provided

Responsible Party:	Yuhan Corporation
ClinicalTrials.gov Identifier:	NCT01750437 History of Changes
Other Study ID Numbers:	YH1885L-201
Study First Received:	December 12, 2012
Last Updated:	May 13, 2013
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Yuhan Corporation:

NERD

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013