Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non Erosive Reflux Disease

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Non-Erosive Gastroesophageal Reflux Disease

Treatments: Drug: DWP14012 A mg; Drug: DWP14012 B mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03811080

DW_DWP14012302

Details and patient eligibility

About

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.

Full description

This is a multi-center, double blind, randomized, placebo-controlled, parallel-group, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (DWP14012 A mg or DWP14012 B mg or placebo).

Enrollment: 327 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects aged between 20 and 75 years
2. Subjects who were not observed mucosal break according to the LA classification(LA grade) on the EGD
3. Subjects who had experienced major symptom within 3 months
4. 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
5. Subjects who is able to understand and follow the instructions
6. Subjects who voluntarily signed written informed consent form

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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327 participants in 3 patient groups, including a placebo group

DWP14012 A mg

Experimental group

Description:

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

Treatment:

Drug: DWP14012 A mg

DWP14012 B mg

Experimental group

Description:

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

Treatment:

Drug: DWP14012 B mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo