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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03928470
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

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

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Study Type : Interventional  (Clinical Trial)
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 29, 2019
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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




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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928470


Locations
Show Show 38 study locations
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Oh Young Lee, M.D., Ph.D. Hanyang University
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03928470    
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases