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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03928470

Recruitment Status Completed

First Posted April 26, 2019

Last update posted December 24, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Non-erosive Reflux Disease(NERD)
  • Intervention/Treatment: Drug: EsoDuo Tab. 20/800mg
  • Phase: Phase 4
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)

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 379 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official Title: 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)
  • Actual Study Start Date: January 2019
  • Actual Primary Completion Date: December 2019
  • Actual Study Completion Date: December 2019
Arms and interventions
Arm Intervention/treatment
Experimental: EsoDuo Tab. 20/800mg
EsoDuo Tab. 20/800mg
Drug: EsoDuo Tab. 20/800mg
Nexium Tab. 20mg
Active Comparator: Nexium Tab. 20mg
Nexium Tab. 20mg
Drug: EsoDuo Tab. 20/800mg
Nexium Tab. 20mg
Outcome Measures
  • Primary Outcome Measures: 1. Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks. [ Time Frame: 4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.
  • Secondary Outcome Measures: 1. Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks. [ Time Frame: 2 weeks after drug administrations ]
    Compare Experimental group with Active Comparator.
  • 2. Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks. [ Time Frame: 2/4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.
  • 3. The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks. [ Time Frame: 2/4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.
  • 4. The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks. [ Time Frame: 2/4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.
  • 5. The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval. [ Time Frame: 2/4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.
  • 6. Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks. [ Time Frame: 2/4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.
  • 7. Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks. [ Time Frame: 4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.
  • 8. Time to first resolution of Heartburn(HB), Day 1 [ Time Frame: 1 day after drug administrations. ]
    Compare Experimental group with Active Comparator.
Eligibility Criteria
  • Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts
Locations
Show 38 Study Locations
Sponsors and Collaborators

Chong Kun Dang Pharmaceutical

Investigators

Principal Investigator: Oh Young Lee, M.D., Ph.D. Hanyang University

More Information
  • Responsible Party: Chong Kun Dang Pharmaceutical
  • ClinicalTrials.gov Identifier: NCT03928470 History of Changes
  • Other Study ID Numbers: 273GERD18019
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: December 24, 2019
  • Last Verified: December 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Gastroesophageal Reflux