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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)

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ClinicalTrials.gov Identifier: NCT01750437
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

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)

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : January 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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: 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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion [ Time Frame: 3 week ]
  3. the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion [ Time Frame: 3 week ]
  4. 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"

  5. 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 ]
  6. Evalution of Clinical Global Impression of Change [ Time Frame: 4 week ]
  7. Evaluation of Patient Global Impression of Change [ Time Frame: 4 week ]
  8. the change of SF-36 Survey score between baseline and completion visit [ Time Frame: 4 week ]
  9. the change of ESS survey score among baseline, 2 week and 4 week [ Time Frame: 2, 4 week ]
    ESS stands for Epworth sleepiness scale.

  10. Safety [ Time Frame: 4 week ]
    AE, Physical exam, 12-lead ECG, Vital signs, laboratory test


Other Outcome Measures:
  1. Comparison of H.pylori(+),(-) subjects about primay and seconday outcome [ Time Frame: 4 week ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01750437     History of Changes
Other Study ID Numbers: YH1885L-201
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014

Keywords provided by Yuhan Corporation:
NERD

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