Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

A Multicenter, Randomized, Double-blind, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg in Patients With Non-erosive Reflux Disease(NERD)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03928470

Enrollment

379

Registered

2019-04-26

Start date

2019-01-29

Completion date

2019-12-20

Last updated

2019-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-erosive Reflux Disease(NERD)

Brief summary

To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

Detailed description

A multicenter, randomized, double-blind, active-controlled phase 4 study to evaluate the efficacy and safety of EsoDuo Tab. 20/800mg in patients with non-erosive reflux disease(NERD)

Interventions

DRUGEsoDuo Tab. 20/800mg

Nexium Tab. 20mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or Female aged ≥ 19 years 2. Episode of heartburn for 3 months or more during prior to randomization visit. 3. Episode of heartburn for 2 days or more during the last 7 days prior to randomization visit. 4. Grade N, M by EGD test.

Exclusion criteria

1. Surgery history on stomach or esophagus 2. Active medical history of stomach, esophagus area 3. Other system disorder which can disturb this trial 4. Patients taking the contraindication of concomitant medications 5. Clinically significant Abnormal Lab test 6. Pregnant woman, Breastfeeding woman.

Design outcomes

Primary

Measure	Time frame	Description
Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks.	4 weeks after drug administrations.	Compare Experimental group with Active Comparator.

Secondary

Measure	Time frame	Description
Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks.	2/4 weeks after drug administrations.	Compare Experimental group with Active Comparator.
The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks.	2/4 weeks after drug administrations.	Compare Experimental group with Active Comparator.
The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks.	2/4 weeks after drug administrations.	Compare Experimental group with Active Comparator.
Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks.	2 weeks after drug administrations	Compare Experimental group with Active Comparator.
Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks.	2/4 weeks after drug administrations.	Compare Experimental group with Active Comparator.
Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks.	4 weeks after drug administrations.	Compare Experimental group with Active Comparator.
Time to first resolution of Heartburn(HB), Day 1	1 day after drug administrations.	Compare Experimental group with Active Comparator.
The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval.	2/4 weeks after drug administrations.	Compare Experimental group with Active Comparator.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026