Phase III Study to Evaluate Safety and Efficacy of Ilaprazole in Patients With NERD
- Registration Number
- NCT03444883
- Lead Sponsor
- Il-Yang Pharm. Co., Ltd.
- 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 Ilaprazole 20 mg to placebo administered once daily for 4 weeks.
- Detailed Description
This study is multicenter, randomized, parallel, double blind, placebo-controlled phase III study
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
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Male or female aged ≥ 19 years and ≤ 80 years
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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
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Voluntarily provide written informed consent to participate in this study
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Esophageal stenosis, ulcerative stenosis, esophagogastric varices or Barrett esophagus confirmed by past upper gastrointestinal endoscopy within 1 year prior to screening
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Active peptic ulcer or gastrointestinal bleeding confirmed by past upper gastrointestinal endoscopy at screening or within 4 weeks prior to screening
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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
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Clinically significant abnormal findings on ECG (major arrhythmia, multifocal PVC, second-degree or higher AV block, etc.) within 3 months prior to screening
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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
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Expected to continuously take nonsteroidal antiinflammatory drugs (NSAIDs) including aspirin or steroid preparations during the study
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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
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Zollinger-Ellison syndrome; past history of alcoholism or drug abuse
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Past history of allergic symptoms (rash, fever, pruritus, etc.) or hypersensitivity to any ingredient of the Investigational product
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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)
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Pregnant or nursing women
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Women of childbearing potential who do not use proper contraception during the study
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Active liver disease; ALT or AST > ULN x 2 at screening; or history of hepatic encephalopathy, esophageal varix, or portacaval shunt
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Receiving renal dialysis or history of kidney transplantation or presence of severe renal impairment (stage 4 or 5 chronic renal disease)
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Participated in another clinical study and took an investigational product within 3 months prior to screening
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Considered by the investigator to be ineligible to participate in this study for other reasons
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group Ilaprazole 10mg Ilaprazole x 2 tablets Control Group Ilaprazole 10mg placebo of Ilaprazole x 2 tablets
- Primary Outcome Measures
Name Time Method Rate of loss of esophagitis symptom at 4 weeks of treatment vs pre-dose 4 weeks(28 days) Percentage of subjects who were assessed as having 'lost' the frequency and intensity of typical esophagitis symptoms by RDQ assessment at 4 weeks of treatment
- Secondary Outcome Measures
Name Time Method Chang in esophagitis symptom score at 4 weeks of treatment vs pre-dose 4 weeks(28 days) The mean scores for esophagitis symptom (heartburn and/or acid regurgitation) frequency and intensity assessed with RDQ (Questions a, b/c, d) and the change in mean score across both domains.
Change in PAGI-QoL score at 4 weeks of treatment vs pre-dose 4 weeks(28 days) The change in mean score for quality of life assessed with PAGI-QoL
Change in esophagitis symptom score according to the maximum number of rescue medication doses per day 4 weeks(28 days) The mean scores for esophagitis symptom (heartburn and/or acid regurgitation) frequency and intensity assessed with RDQ (Questions a, b/c, d) at 4 weeks of treatment versus pre-dose according to the maximum number of rescue medication doses per day and the change in mean score across both domains.
Trial Locations
- Locations (11)
Inje University Busan Paik Hospital
🇰🇷Busan, Busanjin-gu, Korea, Republic of
Kangbuk Samsung Hospital, Sungkyunkwan University
🇰🇷Seoul, Jongno-gu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of
Soon Chun Hyang University Hospital, Buchon
🇰🇷Bucheon, Wonmi-gu, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Seodaemun-gu, Korea, Republic of
Inje University Seoul Paik Hospital
🇰🇷Seoul, Jung-gu, Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
🇰🇷Seoul, Dongjak-gu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Bundang-gu, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Jeonju-si, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Yangcheon-gu, Korea, Republic of