Clinical trial NCT03967886: Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-erosive Reflux Disease
Lead sponsor: Yooyoung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-30
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: Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients

Detailed description: This Phase 3 Clinical Trial is Designed as Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).

Eligibility criteria: Inclusion Criteria:

* A man or woman over 20 years old less than 70 years old.
* A man or woman who has below all characters and diagnosis as NERD.

  1. A man or woman who has experienced symptom(hearburn or/and acid regurgitation) over 3month at least.
  2. A man or woman who has experienced symptom(heartburn or/and acid regurgitation) within 7days before Visit1, meet below 1) or 2) criteria.

     \*\* Symptom (heartburn and acid regurgitation) is confirmed by RDQ
     * Experienced above 2 days in a week, heartburn of acid regurgitation above the weakness.
     * Experienced above 1 day in a week, heartburn of acid regurgitation above the middle.
  3. A man or woman who has been made diagnosis as LA grade0(Zero) measured through the dendoscopy which is corried out within 14 days, there is no observed muscosal break.
* 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 ERD.
* Who get a diagnosis as a IBS within the last 3 months.
* 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 havbe taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
* 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 the gastric or duodenal ulcer, Zollinger-Ellison and other acid hypersecretory condition been experienced.
* Who has hyper-sensitivity, reaction about PPIs (ex. Lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole).
* Who has gotten a diagnosis as a cancer within 5 years before participated in this clinical trail (expect the basal cell on the skin), peptic ulcer or benign tumor.

Primary outcomes:
measure: Recovered percentage(%) of the symptom
timeFrame: within 4 weeks
measure: Change of the score about the symptom
timeFrame: within 4 weeks
measure: Percentage(%) of the patients who have symptom during the daytime
timeFrame: within 4 weeks
measure: Percentage(%) of the patients who have symptom during the nighttime
timeFrame: within 4 weeks
measure: Percentage(%) of the days no symtom
timeFrame: within 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Ansan Hospital
Study officials:
References: