Non-erosive Gastroesphageal Reflux Disease Clinical Trial
Official title:
A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase 3 Study to Compare Efficacy and Safety of HIP1601 in Patients With Non-Erosive Gastroesophageal Reflux Disease(NERD)
| Verified date | November 2022 |
| Source | Hanmi Pharmaceutical Company Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.
| Status | Completed |
| Enrollment | 208 |
| Est. completion date | August 3, 2020 |
| Est. primary completion date | August 3, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 75 Years |
| Eligibility | Inclusion Criteria: - 19= age = 75 - Patients who were not observed mucosal break('not present') according to the LA classification(LA grade) on the EGDEsophago-Gastro-Duodenoscopy - Patients who had experienced major symptom within 3 months Patients experienced heartburn or acid regurgitation within 7 days of screening day - Patients who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week based on RDQ - Patients understood the consents and purpose of this trial and signed consent form Exclusion Criteria: - Patients who have erosive GERD, Barrett's esophagus(other significant dysplasia of esophagus), gastroesophageal varicose veins, active peptic ulcer, gastrointestinal bleeding or malignant GI tumor confirmed by endoscopy - Patients who have a history of gastric or gastroesophageal surgery - Patients who have Zollinger-Ellison syndrome, eosinophilic esophagitis, primary esophageal motility disorder, acute upper gastrointestinal bleeding, Functional dyspepsia, IBS, IBD within 3 months before Visit 1 - Patients with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease. - Patients Has a severe liver disorder(AST or ALT level exceeds 3 times more than normal upper range at Visit 1) - Has a clinically significant renal failure(MDRD eGFR = 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL at Visit 1) |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi-do |
| Lead Sponsor | Collaborator |
|---|---|
| Hanmi Pharmaceutical Company Limited |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of patients with complete resolution of major symptoms at 4-week | Complete resolution is defined as no episodes of symptom during the last 7 days of treatment. | 4 week | |
| Secondary | Percentage of patients with complete resolution of major symptoms at 2-week | Complete resolution is defined as no episodes of symptom during the last 7 days of treatment | 2 week | |
| Secondary | Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ) | RDQ frequncy and severity score is 0 to 5 point scale, high score mean a worse outcome. | 2, 4 week | |
| Secondary | Time to complete resolution of major symptoms | defined as time to the first day of complete resolution | 4 week | |
| Secondary | Resolution rate of major symptoms of first 7 days | defined as first of 7 days with no episodes of symptom using subject's diary | 1 week | |
| Secondary | Major symptoms-Free days | Major symptoms-Free days mean rate of days that symtom's severity score is '0' using subject's diary | 1, 4 week | |
| Secondary | Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL) | PAGI-QoL total score is 0 to 30 point scale, high score mean a better outcome. | 4 week | |
| Secondary | Proportion of rescue medication amounts | Use of rescue medication | 4 week |