Clinical trial NCT03943992: Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erosive Esophagitis
Lead sponsor: Yooyoung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-09
Enrollment: 170
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: LA grade 0(zero)
timeFrame: within 8 weeks
Secondary outcomes:
measure: LA grade 0(zero)
timeFrame: at 4 weeks
measure: Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire).
timeFrame: at week 4 and 8 from baseline
measure: Frequency variation of the Heartburn in daytime by patients diary
timeFrame: at 4 week and 8 week from baseline
measure: Frequency variation of the Heartburn in nighttime by patients diary
timeFrame: at 4 week and 8 week from baseline
measure: Days percentage(%) of no symptoms about the Heartburn and acid regurgitation
timeFrame: at week 4 and 8 from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Ansan Hospital
Study officials:
References: