Status and phase
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About
The purpose of this study is to evaluate the efficacy and safety of Ilaprazole 20 mg in patients with non-erosive reflux disease. This study intends to demonstrate the clinical superiority of Ilaprazole 20 mg to placebo administered once daily for 4 weeks.
Full description
This study is multicenter, randomized, parallel, double blind, placebo-controlled phase III study
Enrollment
Sex
Ages
Volunteers
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 3 months before screening 2-2) Have experienced at least either heartburn or acid regurgitation of moderate or higher intensity on at least 2 days of 7 days prior to initiation of the investigational product 2-3) Esophageal mucosal breaks by LA Classification are not observed on upper gastrointestinal endoscopy at screening
Voluntarily provide written informed consent to participate in this study
Exclusion criteria
Esophageal stenosis, ulcerative stenosis, esophagogastric varices or Barrett esophagus confirmed by past upper gastrointestinal endoscopy within 1 year prior to screening
Active peptic ulcer or gastrointestinal bleeding confirmed by past upper gastrointestinal 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) Alkaline Phosphatase, 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, mucosal protective drugs, prokinetics, etc. within 2 weeks prior to initiation of the investigational product administration, or has taken PPIs within 4 weeks prior to initiation of the investigational product administration
Expected to continuously take nonsteroidal antiinflammatory drugs (NSAIDs) including aspirin 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: history of major gastrointestinal surgery such as gastrectomy, gastroenterostomy, colectomy, gastric bypass, gastric ligation or gastric banding; presence or history of active inflammatory bowel disease within 12 months prior to screening; has undergone critical surgery that may influence gastric acid secretion with exception of surgeries such as appendectomy, cholecystectomy, and hysterectomy
Zollinger-Ellison syndrome; past history of alcoholism or drug abuse
Past history of allergic symptoms (rash, fever, pruritus, etc.) or hypersensitivity to any ingredient of the Investigational product
Past history of treated or untreated malignancy, with or without local recurrence or metastasis, within 5 years prior to screening (with exception of local basal cell carcinoma 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 hepatic encephalopathy, esophageal varix, or portacaval shunt
Receiving renal dialysis or history of kidney transplantation or presence of severe renal impairment (stage 4 or 5 chronic renal disease)
Participated in another clinical study and took an investigational product within 3 months prior to screening
Considered by the investigator to be ineligible to participate in this study for other reasons
Primary purpose
Allocation
Interventional model
Masking
277 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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