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Completed

NCT Number: NCT03928470

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

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

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Key information

Conditions

Non-erosive Reflux Disease(NERD) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Non-Erosive Reflux Disease

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dong-A University Hospital, Busan, South Korea

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

EsoDuo Tab. 20/800mg

Drug

Nexium Tab. 20mg

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2019
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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