NCT01538849

Brief Summary

This study is to investigate the optimal clinical dose and administration methods of YH4808 in patients with reflux esophagitis by evaluating the safety and efficacy after YH4808 oral administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

February 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

11 months

First QC Date

February 20, 2012

Last Update Submit

July 8, 2014

Conditions

Reflux Esophagitis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Healing of Reflux Esophagitis (RE) Who Were "Normal(including minimal change)" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification

    Week 4

Secondary Outcomes (8)

  • Number of Participants With Healing of Reflux Esophagitis (RE) Who Were "Normal(including minimal change)" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification

    Week 8

  • Nocturnal Symptom Free Days & Symptom Free Days

    Treatment Period

  • Sustained resolution of symptom & Time to first sustained symptom resolution

    Treatment Period

  • Symptom Score

    Treatment Period

  • Serum Gastrin Level

    Check at Baseline(Pre-dose), 2, 4, and 8 weeks.

  • +3 more secondary outcomes

Other Outcomes (6)

  • Nocturnal Symptom Free Days & Symptom Free Days

    Follow-up period

  • Sustained resolution of symptom

    Follow-up period

  • Symptom Score

    Follow-up period

  • +3 more other outcomes

Study Arms (5)

YH4808 A mg (Twice daily)

EXPERIMENTAL

YH4808 A mg (Twice daily, Oral administration)

Drug: YH4808 A mg

YH4808 B mg (Once daily)

EXPERIMENTAL

YH4808 B mg (Once daily, Oral administration)

Drug: YH4808 B mg

YH4808 B mg (Twice daily)

EXPERIMENTAL

YH4808 B mg (Twice daily, Oral administration)

Drug: YH4808 B mg

YH4808 C mg (Once daily)

EXPERIMENTAL

YH4808 C mg (Once daily, Oral administration)

Drug: YH4808 C mg

Esomeprazole 40mg (Once daily)

ACTIVE COMPARATOR

Esomeprazole 40mg (Once daily, Oral administration)

Drug: Esomeprazole 40mg

Interventions

Esomeprazole 40mgDRUG

1 tablet = Esomeprazole 40 mg

Also known as: Nexium
Esomeprazole 40mg (Once daily)
YH4808 A mgDRUG

1 tablet = YH4808 A mg

Also known as: Undecided
YH4808 A mg (Twice daily)
YH4808 B mgDRUG

1 tablet = YH4808 B mg

Also known as: Undecided
YH4808 B mg (Once daily)YH4808 B mg (Twice daily)
YH4808 C mgDRUG

YH4808 C mg = 2 x YH4808 B mg

Also known as: Undecided
YH4808 C mg (Once daily)

Eligibility Criteria

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

You may qualify if:

  • Subject who has signed on the written consent
  • Male and female aged 20 and over
  • Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 2 weeks before randomisation

You may not qualify if:

  • History or presence of upper gastrointestinal anatomic or motor disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul ST.MARY'S HOSPITAL

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Esophagitis, Peptic

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Myung Gyy Choi, M.D., Ph.D.

    Catholic Univ. Seoul St. Mary Hospital

    PRINCIPAL INVESTIGATOR

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

February 20, 2012

First Posted

February 24, 2012

Study Start

December 1, 2012

Primary Completion

November 1, 2013

Study Completion

May 1, 2014

Last Updated

July 10, 2014

Record last verified: 2014-07

Locations

KR(1)