Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study is multicenter, randomized, parallel, double blind, placebo-controlled phase III study
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | 10mg Ilaprazole x 2 tablets |
|
| Control Group | Placebo Comparator | 10mg placebo of Ilaprazole x 2 tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ilaprazole | Drug | 10mgx2 tablet once daily for weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of loss of esophagitis symptom at 4 weeks of treatment vs pre-dose | 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 | 4 weeks(28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Chang in esophagitis symptom score at 4 weeks of treatment vs pre-dose | 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. | 4 weeks(28 days) |
| Change in PAGI-QoL score at 4 weeks of treatment vs pre-dose |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| DongHo Lee, MD.PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Bundang-gu | South Korea | |||
| Inje University Busan Paik Hospital |
IPD will not be shared to other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
A mulicenter, randomized, parallel, double blind, placebo-controlled
Not provided
Not provided
Not provided
The change in mean score for quality of life assessed with PAGI-QoL |
| 4 weeks(28 days) |
| Change in esophagitis symptom score according to the maximum number of rescue medication doses per day | 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. | 4 weeks(28 days) |
| Busan |
| Busanjin-gu |
| South Korea |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | Dongjak-gu | South Korea |
| Chonbuk National University Hospital | Jeonju | Jeonju-si | South Korea |
| Kangbuk Samsung Hospital, Sungkyunkwan University | Seoul | Jongno-gu | South Korea |
| Seoul National University Hospital | Seoul | Jongno-gu | South Korea |
| Inje University Seoul Paik Hospital | Seoul | Jung-gu | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | Seodaemun-gu | South Korea |
| Asan Medical Center | Seoul | Songpa-gu | South Korea |
| Soon Chun Hyang University Hospital, Buchon | Bucheon-si | Wonmi-gu | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | Yangcheon-gu | South Korea |
| ID | Term |
|---|---|
| D000096663 | Non-Erosive Reflux Disease |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C119615 | ilaprazole |
Not provided
Not provided
Not provided