Status:
COMPLETED
Phase III Study to Evaluate Safety and Efficacy of Ilaprazole in Patients With NERD
Lead Sponsor:
Il-Yang Pharm. Co., Ltd.
Conditions:
Non-erosive Reflux Disease
Eligibility:
All Genders
19-80 years
Phase:
PHASE3
Brief Summary
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 Ilaprazo...
Detailed Description
This study is multicenter, randomized, parallel, double blind, placebo-controlled phase III study
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2020
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT03444883
Start Date
October 31 2018
End Date
February 25 2020
Last Update
January 5 2021
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu, South Korea
2
Inje University Busan Paik Hospital
Busan, Busanjin-gu, South Korea
3
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Dongjak-gu, South Korea
4
Chonbuk National University Hospital
Jeonju, Jeonju-si, South Korea