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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01750437
First received: December 12, 2012
Last updated: July 8, 2014
Last verified: July 2014
  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:


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 ]

Enrollment: 149
Study Start Date: January 2013
Study Completion Date: April 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
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
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: July 8, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yuhan Corporation:
NERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014