NCT04309916

Brief Summary

This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2020

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

March 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

March 13, 2020

Last Update Submit

February 9, 2022

Conditions

Erosive Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • Time to first nighttime heartburn-free interval (days))

    Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.

    2 week

Secondary Outcomes (1)

  • Percentage of days without nighttime heartburn during the 2-week dosing period

    2 week

Study Arms (2)

Tegoprazan 50mg

EXPERIMENTAL

Tegoprazan 50mg tablet, once daily, oral administration

Drug: Tegoprazan

Esomeprazole 40mg

ACTIVE COMPARATOR

Esomeprazole 40mg tablet, once daily, oral administration

Drug: Esomeprazole

Interventions

TegoprazanDRUG

Tegoprazan 50mg tablet

Tegoprazan 50mg
EsomeprazoleDRUG

Esomeprazole 40mg tablet

Esomeprazole 40mg

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged between 19 and 75 years
  • Subjects who have erosive reflux disease

You may not qualify if:

  • Unable to undergo upper GI endoscopy
  • Symptoms of primary or secondary esophageal movement disorders
  • Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Interventions

tegoprazanEsomeprazole

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sang Kil Lee, Ph.D

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 17, 2020

Study Start

May 22, 2020

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

KR(1)