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

• ClinicalTrials.gov Identifier: NCT03444883
• Recruitment Status: Completed
• First Posted: February 23, 2018
• Last Update Posted: January 5, 2021
• Sponsor: Il-Yang Pharm. Co., Ltd.
• Information provided by (Responsible Party): Il-Yang Pharm. Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-erosive Reflux Disease	Drug: Ilaprazole	Phase 3

Detailed Description:

This study is multicenter, randomized, parallel, double blind, placebo-controlled phase III study

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 277 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A mulicenter, randomized, parallel, double blind, placebo-controlled
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Parallel, Double Blind, Placebo-controlled Phase III Study to Evaluate Safety and Efficacy of Ilaprazole 20mg in Patients With Non-erosive Reflux Disease(NERD)
• Actual Study Start Date: October 31, 2018
• Actual Primary Completion Date: February 25, 2020
• Actual Study Completion Date: February 25, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Treatment Group; 10mg Ilaprazole x 2 tablets	Drug: Ilaprazole; 10mgx2 tablet once daily for weeks; Other Name: IY81149
Placebo Comparator: Control Group; 10mg placebo of Ilaprazole x 2 tablets	Drug: Ilaprazole; 10mgx2 tablet once daily for weeks; Other Name: IY81149

Outcome Measures

Primary Outcome Measures :

1. Rate of loss of esophagitis symptom at 4 weeks of treatment vs pre-dose [ Time Frame: 4 weeks(28 days) ]
   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

Secondary Outcome Measures :

1. Chang in esophagitis symptom score at 4 weeks of treatment vs pre-dose [ Time Frame: 4 weeks(28 days) ]
   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.
2. Change in PAGI-QoL score at 4 weeks of treatment vs pre-dose [ Time Frame: 4 weeks(28 days) ]
   The change in mean score for quality of life assessed with PAGI-QoL
3. Change in esophagitis symptom score according to the maximum number of rescue medication doses per day [ Time Frame: 4 weeks(28 days) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Korea, Republic of

Seoul National University Bundang Hospital

Seongnam-si, Bundang-gu, Korea, Republic of

Inje University Busan Paik Hospital

Busan, Busanjin-gu, Korea, Republic of

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, Dongjak-gu, Korea, Republic of

Chonbuk National University Hospital

Jeonju, Jeonju-si, Korea, Republic of

Kangbuk Samsung Hospital, Sungkyunkwan University

Seoul, Jongno-gu, Korea, Republic of

Seoul National University Hospital

Seoul, Jongno-gu, Korea, Republic of

Inje University Seoul Paik Hospital

Seoul, Jung-gu, Korea, Republic of

Severance Hospital Yonsei University Health System

Seoul, Seodaemun-gu, Korea, Republic of

Asan Medical Center

Seoul, Songpa-gu, Korea, Republic of

Soon Chun Hyang University Hospital, Buchon

Bucheon, Wonmi-gu, Korea, Republic of

Ewha Womans University Mokdong Hospital

Seoul, Yangcheon-gu, Korea, Republic of

Sponsors and Collaborators

Il-Yang Pharm. Co., Ltd.

Investigators

• Principal Investigator: DongHo Lee, MD.PhD; Seoul National University Bundang Hospital

More Information

• Responsible Party: Il-Yang Pharm. Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03444883
• Other Study ID Numbers: IL49NE03
• First Posted: February 23, 2018
• Last Update Posted: January 5, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: IPD will not be shared to other researchers.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Il-Yang Pharm. Co., Ltd.:

NERD; PPI; Ilaprazole

Additional relevant MeSH terms:

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases