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

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ClinicalTrials.gov Identifier: NCT03943992
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Yooyoung Pharmaceutical Co., Ltd.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Erosive Esophagitis Drug: YYD601 40mg Drug: Nexium 40mg Drug: Placebos Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official 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).
Estimated Study Start Date : May 21, 2019
Estimated Primary Completion Date : June 12, 2019
Estimated Study Completion Date : June 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: YYD601 40mg
Esomeprazole magnesium Dihydrate.
Drug: YYD601 40mg
Patients should take druges 30 minutes before breakfast.

Drug: Placebos
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.

Active Comparator: Nexium 40mg
Esomeprazole magnesium trihydrate, a substituted benzimidazole.
Drug: Nexium 40mg
Patients should take druges 30 minutes before breakfast.

Drug: Placebos
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

    1. Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness.
    2. 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.

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): NCT03943992


Contacts
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Contact: Min-Kyung Kwon +82-2-6207-6114 monica.kim@yypharm.co.kr
Contact: Ye Rum Kim +82-2-6202-7121 monica.kim@yypharm.co.kr

Locations
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Korea, Republic of
Korea University Ansan Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Sang-Woo Lee    +82-31-412-5580    leesw@kumc.or.kr   
Sponsors and Collaborators
Yooyoung Pharmaceutical Co., Ltd.

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Responsible Party: Yooyoung Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03943992     History of Changes
Other Study ID Numbers: YYPCT_YYD601_P3
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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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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Esophagitis
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Esophageal Motility Disorders
Deglutition Disorders
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action