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)

Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease

Sponsors

Lead sponsor: Hanmi Pharmaceutical Company Limited

Source Hanmi Pharmaceutical Company Limited
Brief Summary

The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.

Detailed Description

A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 in Patients with Non-Erosive Gastroesophageal Reflux Disease(NERD)

Overall Status Recruiting
Start Date April 16, 2019
Completion Date December 16, 2020
Primary Completion Date July 16, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of patients with complete resolution of major symptoms at 4-week 4 week
Secondary Outcome
Measure Time Frame
Percentage of patients with complete resolution of major symptoms at 2-week 2 week
Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ) 2, 4 week
Time to complete resolution of major symptoms 4 week
Resolution rate of major symptoms of first 7 days 1 week
Major symptoms-Free days 1, 4 week
Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL) 4 week
Proportion of rescue medication amounts 4 week
Enrollment 212
Condition
Intervention

Intervention type: Drug

Intervention name: HIP1601

Description: HIP1601

Arm group label: HIP1601 Amg

Intervention type: Drug

Intervention name: HGP1805

Description: Placebo of HIP1601

Arm group label: HGP1805

Eligibility

Criteria:

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)

Gender: All

Minimum age: 19 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Contact

Last name: Jung Jin-A, Ph.D

Phone: (82)-2-410-9038

Email: [email protected]

Location
facility status contact investigator Seoul National University Bundang Hospital Kim Na-Young, MD, PhD (82)-31-787-7008 [email protected] Kim Na-Young, MD, PhD Principal Investigator
Location Countries

Korea, Republic of

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: HIP1601 Amg

Arm group type: Experimental

Description: The participants will receive tretment of HIP1601 Amg, orally, once daily for 4weeks.

Arm group label: HGP1805

Arm group type: Placebo Comparator

Description: The participants will receive tretment of HGP1805(Placebo of HIP1601), orally, once daily for 4weeks.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov