Phase III Study to Evaluate Safety and Efficacy of Ilaprazole in Patients With NERD

NCT ID: NCT03444883

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 277 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2020-02-25

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

Conditions

Non-erosive Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment Group

10mg Ilaprazole x 2 tablets

Group Type: ACTIVE_COMPARATOR

Ilaprazole

Intervention Type: DRUG

10mgx2 tablet once daily for weeks

Control Group

10mg placebo of Ilaprazole x 2 tablets

Group Type: PLACEBO_COMPARATOR

Ilaprazole

Intervention Type: DRUG

10mgx2 tablet once daily for weeks

Interventions

Ilaprazole

10mgx2 tablet once daily for weeks

Intervention Type: DRUG

Other Intervention Names

IY81149

Eligibility Criteria

Inclusion Criteria

1. Male or female aged ≥ 19 years and ≤ 80 years

2. 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

3. Voluntarily provide written informed consent to participate in this study

Exclusion Criteria

1. Esophageal stenosis, ulcerative stenosis, esophagogastric varices or Barrett esophagus confirmed by past upper gastrointestinal endoscopy within 1 year prior to screening

2. Active peptic ulcer or gastrointestinal bleeding confirmed by past upper gastrointestinal endoscopy at screening or within 4 weeks prior to screening

3. 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

4. Clinically significant abnormal findings on ECG (major arrhythmia, multifocal PVC, second-degree or higher AV block, etc.) within 3 months prior to screening

5. 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

6. Expected to continuously take nonsteroidal antiinflammatory drugs (NSAIDs) including aspirin or steroid preparations during the study

7. 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

8. Zollinger-Ellison syndrome; past history of alcoholism or drug abuse

9. Past history of allergic symptoms (rash, fever, pruritus, etc.) or hypersensitivity to any ingredient of the Investigational product

10. 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)

11. Pregnant or nursing women

12. Women of childbearing potential who do not use proper contraception during the study

13. Active liver disease; ALT or AST > ULN x 2 at screening; or history of hepatic encephalopathy, esophageal varix, or portacaval shunt

14. Receiving renal dialysis or history of kidney transplantation or presence of severe renal impairment (stage 4 or 5 chronic renal disease)

15. Participated in another clinical study and took an investigational product within 3 months prior to screening

16. Considered by the investigator to be ineligible to participate in this study for other reasons

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Il-Yang Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

DongHo Lee, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Bundang-gu, South Korea

Inje University Busan Paik Hospital

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

Countries

South Korea

Other Identifiers

IL49NE03

Identifier Type: -

Identifier Source: org_study_id