Phase
Condition
Esophageal Disorders
Gastroesophageal Reflux Disease (Gerd)
Heartburn (Pediatric)
Treatment
N/AClinical Study ID
Ages 19-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female aged ≥ 19 years and ≤ 80 years
- Diagnosed with non-erosive reflux disease meeting all of the following criteria: 2-1) At least either heartburn or acid regurgitation has persisted for at least past 3months before screening 2-2) Have experienced at least either heartburn or acidregurgitation of moderate or higher intensity on at least 2 days of 7 days prior toinitiation of the investigational product 2-3) Esophageal mucosal breaks by LAClassification are not observed on upper gastrointestinal endoscopy at screening
- Voluntarily provide written informed consent to participate in this study
Exclusion
Exclusion Criteria:
- Esophageal stenosis, ulcerative stenosis, esophagogastric varices or Barrett esophagusconfirmed by past upper gastrointestinal endoscopy within 1 year prior to screening
- Active peptic ulcer or gastrointestinal bleeding confirmed by past uppergastrointestinal endoscopy at screening or within 4 weeks prior to screening
- Abnormal value on laboratory test at screening: 3-1) Total Bilirubin, Creatinine > Upper limit of normal (ULN) x 1.5 3-2) AlkalinePhosphatase, BUN > ULN x 2
- Clinically significant abnormal findings on ECG (major arrhythmia, multifocal PVC,second-degree or higher AV block, etc.) within 3 months prior to screening
- Have taken H2 receptor antagonists (H2RA), prostaglandin preparations, mucosalprotective drugs, prokinetics, etc. within 2 weeks prior to initiation of theinvestigational product administration, or has taken PPIs within 4 weeks prior toinitiation of the investigational product administration
- Expected to continuously take nonsteroidal antiinflammatory drugs (NSAIDs) includingaspirin or steroid preparations during the study
- Surgical or medical condition that may significantly influence the absorption,distribution, metabolism or excretion of drug, including but not limited to: historyof major gastrointestinal surgery such as gastrectomy, gastroenterostomy, colectomy,gastric bypass, gastric ligation or gastric banding; presence or history of activeinflammatory bowel disease within 12 months prior to screening; has undergone criticalsurgery that may influence gastric acid secretion with exception of surgeries such asappendectomy, cholecystectomy, and hysterectomy
- Zollinger-Ellison syndrome; past history of alcoholism or drug abuse
- Past history of allergic symptoms (rash, fever, pruritus, etc.) or hypersensitivity toany ingredient of the Investigational product
- Past history of treated or untreated malignancy, with or without local recurrence ormetastasis, within 5 years prior to screening (with exception of local basal cellcarcinoma of skin)
- Pregnant or nursing women
- Women of childbearing potential who do not use proper contraception during the study
- Active liver disease; ALT or AST > ULN x 2 at screening; or history of hepaticencephalopathy, esophageal varix, or portacaval shunt
- Receiving renal dialysis or history of kidney transplantation or presence of severerenal impairment (stage 4 or 5 chronic renal disease)
- Participated in another clinical study and took an investigational product within 3months prior to screening
- Considered by the investigator to be ineligible to participate in this study for otherreasons
Study Design
Study Description
Connect with a study center
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu
Korea, Republic ofSite Not Available
Inje University Busan Paik Hospital
Busan, Busanjin-gu
Korea, Republic ofSite Not Available
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Dongjak-gu
Korea, Republic ofSite Not Available
Chonbuk National University Hospital
Jeonju, Jeonju-si
Korea, Republic ofSite Not Available
Kangbuk Samsung Hospital, Sungkyunkwan University
Seoul, Jongno-gu
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, Jongno-gu
Korea, Republic ofSite Not Available
Inje University Seoul Paik Hospital
Seoul, Jung-gu
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, Seodaemun-gu
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, Songpa-gu
Korea, Republic ofSite Not Available
Soon Chun Hyang University Hospital, Buchon
Bucheon, Wonmi-gu
Korea, Republic ofSite Not Available
Ewha Womans University Mokdong Hospital
Seoul, Yangcheon-gu
Korea, Republic ofSite Not Available
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