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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03943992

Recruitment Status Not yet recruiting

First Posted May 9, 2019

Last update posted May 30, 2019

Study Description

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:Erosive Esophagitis
  • Intervention/Treatment: Drug: YYD601 40mg
    Drug: Nexium 40mg
    Drug: Placebos
  • Phase: 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.

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: June 2019
  • Estimated Study Completion Date: June 2019
Arms and interventions
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.
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 20 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.

Contacts and Locations
Contacts

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

Korea, Republic of
Korea University Ansan Hospital
Seoul

Sponsors and Collaborators

Yooyoung Pharmaceutical Co., Ltd.

More Information
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Esophagitis Gastroesophageal Reflux