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Completed

NCT Number: NCT03943992

Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)

A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).

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Key information

Conditions

Erosive Esophagitis

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Ansan Hospital

Seoul, South Korea

About this study

This phase 3 clinical trial is designed as randomized, active-comparator, double-dummy, multi-center for ERD patients, who take YYD601 40mg or Nexium 40mg for 8 weeks. Each part is assessed by 'LA grade' measured through the endoscopy, target goal is to confirm the non-inferiority of YYD601 40mg to Nexium 40mg.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A man or woman over 20 years old less than 70 years old.
  • A man or woman who has experienced symptom (heartburn and acid regurgitation) within 7 days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as Erosive esophagitis(LA grade A~D) measured through the endoscopy which is carried out within (-2W±D2)
  • Symptom (heartburn and acid regurgitation) is confirmed by RDQ.
  • Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness.
  • Experienced above 1 day in 1 week, Heartburn of acid regurgitation above the middle.
  • A man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial.

Exclusion criteria

  • Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole.
  • Who has NERD
  • Who get a diagnosis as a IBS within the last 3 months.
  • Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
  • Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA) Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (* refer to the Concomitant medication in text.)
  • Who has been experienced the disease affecting the esophagus(Eosinophilic esophagitis, esophageal varices, cirrhosis, Virus or Fungal infection, Esophageal stricture, primary esophageal motility disorder and gastrointestinal bleeding). Or who has a history of radio therapeutics, freeze treatment about the esophagus.
  • Who has clinically significant abnormal result of ECG.
  • Abnormal result of Major arrhythmia, Multifocal PVS, 2 AV-blcok etc.
  • Who has the Schatzki near the LES(lower esophageal sphincter) except the Barret's esophagus.

Treatment and study plan

YYD601 40mg

Drug

Patients should take druges 30 minutes before breakfast.

Nexium 40mg

Drug

Patients should take druges 30 minutes before breakfast.

Placebos

Drug

The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients.

Primary outcomes

  1. LA grade 0(zero)

    Time frame: within 8 weeks

    Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) within week 8.

    Calculation of the sample size was based on a margin of non-inferiority by Normal approximation.

Secondary outcomes

  1. LA grade 0(zero)

    Time frame: at 4 weeks

    Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) by Normal approximation and Fisher's exact test.

  2. Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire).

    Time frame: at week 4 and 8 from baseline

    Change in frequency of the symptom(heartburn and acid regurgitation) by Shapiro-Wilk test and Wilcoxon's rank sum test.

  3. Frequency variation of the Heartburn in daytime by patients diary

    Time frame: at 4 week and 8 week from baseline

    Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test.

  4. Frequency variation of the Heartburn in nighttime by patients diary

    Time frame: at 4 week and 8 week from baseline

    Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test.

  5. Days percentage(%) of no symptoms about the Heartburn and acid regurgitation

    Time frame: at week 4 and 8 from baseline

    Patients who have experienced the heartburn and acid regurgitation in nighttime by patients diary.

Sponsors and collaborators

Lead sponsor

Yooyoung Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Double-dummy, Active Comparator, Multi-centers, Non-inferiority Design Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD) (Phase3).

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 9, 2019
Registry last updated
May 11, 2021

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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