NCT03811080

Brief Summary

The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
327

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

January 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

January 17, 2019

Last Update Submit

June 23, 2019

Conditions

Non-Erosive Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • 1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week

    defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)

    4 week

Secondary Outcomes (4)

  • Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)

    2 week, 4 week

  • Reflux disease symptom assessment using Subject diary

    4 week

  • Quality of Life assessment using PAGI-QoL

    4 week

  • Use of rescue medication

    4 week

Study Arms (3)

DWP14012 A mg

EXPERIMENTAL

DWP14012 A mg, tablet, once daily, oral administration for up to 4 weeks

Drug: DWP14012 A mg

DWP14012 B mg

EXPERIMENTAL

DWP14012 B mg, tablet, once daily, oral administration for up to 4 weeks

Drug: DWP14012 B mg

Placebo

PLACEBO COMPARATOR

Placebo, tablet, once daily, oral administration for up to 4 weeks

Drug: Placebo

Interventions

DWP14012 A mgDRUG

The participants will receive treatment of DWP14012 A mg, tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.

DWP14012 A mg
DWP14012 B mgDRUG

The participants will receive treatment of DWP14012 B mg, tablet, orally, once daily and DWP14012 A mg placebo-matching tablet, orally, once daily for up to 4 weeks.

DWP14012 B mg
PlaceboDRUG

The participants will receive treatment of DWP14012 A mg placebo-matching tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged between 20 and 75 years
  • Subjects who were not observed mucosal break according to the LA classification(LA grade) on the EGD
  • Subjects who had experienced major symptom within 3 months
  • Subjects who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week
  • Subjects who is able to understand and follow the instructions
  • Subjects who voluntarily signed written informed consent form

You may not qualify if:

  • Subjects who have Barrett's esophagus, gastroesophageal varices, esophageal stenosis, ulcer stenosis, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by endoscopy
  • Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers within 2 months before Visit 1
  • Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD in the last 3 months
  • Subjects who have a history of gastric acid suppression surgery or gastroesophageal surgery
  • Subjects with Zollinger-Ellison syndrome
  • Subjects with eosinophilic esophagitis
  • Subjects with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University Medical Center

Seoul, South Korea

RECRUITING

Central Study Contacts

Daewoong Pharmaceutical Co. LTD.

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
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

January 17, 2019

First Posted

January 22, 2019

Study Start

February 7, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

June 25, 2019

Record last verified: 2019-06

Locations

KR(1)