NCT01750437

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

December 12, 2012

Last Update Submit

July 8, 2014

Conditions

Non-erosive Reflux Disease

Keywords

NERD

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 week

Secondary Outcomes (10)

  • the rate of subject who had 'appropriate recovery' of symptom after 4 week administration

    4 week

  • the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion

    3 week

  • the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion

    3 week

  • the number of night symptom-free day after IP administration

    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

    1 week, 2 week, 3 week, 4 week

  • +5 more secondary outcomes

Other Outcomes (1)

  • Comparison of H.pylori(+),(-) subjects about primay and seconday outcome

    4 week

Study Arms (5)

YH1885L 33.3 mg

EXPERIMENTAL

TID, Subject takes it for 4 week.

Drug: YH1885L(Revaprazan)

YH1885L 50mg

EXPERIMENTAL

BID, Subject takes it for 4 week.

Drug: YH1885L(Revaprazan)Drug: placebo

YH1885L 66.6 mg

EXPERIMENTAL

TID, Subject takes it for 4 week.

Drug: YH1885L(Revaprazan)

YH1885L 100mg

EXPERIMENTAL

BID, Subject takes it for 4 week.

Drug: YH1885L(Revaprazan)Drug: placebo

Esomeprazole 20mg

ACTIVE COMPARATOR

QD, Subject takes it for 4 week.

Drug: Esomeprazole 20mgDrug: placebo

Interventions

YH1885L(Revaprazan)DRUG
YH1885L 100mgYH1885L 33.3 mgYH1885L 50mgYH1885L 66.6 mg
Esomeprazole 20mgDRUG
Also known as: Nexium
Esomeprazole 20mg
placeboDRUG
Esomeprazole 20mgYH1885L 100mgYH1885L 50mg

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Catholic yeouido sungmo hospital

Seoul, Seoul, South Korea

Location

DongA university hospital

Busan, South Korea

Location

Kyungbook University hospital

Daegu, South Korea

Location

Chungnam university hospital

Daejeon, South Korea

Location

Catholic Incheon hospital

Incheon, South Korea

Location

Jeonbuk University hospital

Jeonju, South Korea

Location

Asan hospital

Seoul, South Korea

Location

Konkuk unversity hospital

Seoul, South Korea

Location

Kyunghee university hospital

Seoul, South Korea

Location

Seoul university hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Gastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 17, 2012

Study Start

January 1, 2013

Primary Completion

October 1, 2013

Study Completion

April 1, 2014

Last Updated

July 10, 2014

Record last verified: 2014-07

Locations

KR(10)