Phase III Study to Evaluate Safety and Efficacy of Ilaprazole in Patients With NERD (NCT03444883) | Clinical Trial Compass
CompletedPhase 3
Phase III Study to Evaluate Safety and Efficacy of Ilaprazole in Patients With NERD
South Korea277 participantsStarted 2018-10-31
Plain-language 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.
Who can participate
Age range19 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male or female aged ≥ 19 years and ≤ 80 years
✓. Diagnosed with non-erosive reflux disease meeting all of the following criteria:
✓. 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:
✕. 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
What they're measuring
1
Rate of loss of esophagitis symptom at 4 weeks of treatment vs pre-dose