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

NCT03444883 | Completed Phase 3

• 1 other identifier: IL49NE03
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 11

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.

Conditions

Non-erosive Reflux Disease

Keywords

NERD; PPI; Ilaprazole

Outcome Measures

Primary Outcomes (1)

• Rate of loss of esophagitis symptom at 4 weeks of treatment vs pre-dose

  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

  4 weeks(28 days)

Secondary Outcomes (3)

• Chang in esophagitis symptom score at 4 weeks of treatment vs pre-dose

  4 weeks(28 days)

• Change in PAGI-QoL score at 4 weeks of treatment vs pre-dose

  4 weeks(28 days)

• Change in esophagitis symptom score according to the maximum number of rescue medication doses per day

  4 weeks(28 days)

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

10mg Ilaprazole x 2 tablets

Drug: Ilaprazole

Control Group

PLACEBO COMPARATOR

10mg placebo of Ilaprazole x 2 tablets

Drug: Ilaprazole

Interventions

Ilaprazole DRUG

10mgx2 tablet once daily for weeks

Also known as: IY81149

Control Group; Treatment Group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥ 19 years and ≤ 80 years
• Diagnosed with non-erosive reflux disease meeting all of the following criteria:
• ) 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
• Voluntarily provide written informed consent to participate in this study

You may not qualify if:

• 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:
• ) Total Bilirubin, Creatinine \> Upper limit of normal (ULN) x 1.5 3-2) Alkaline Phosphatase, BUN \> ULN x 2
• 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
• Zollinger-Ellison syndrome; past history of alcoholism or drug abuse
• Past history of allergic symptoms (rash, fever, pruritus, etc.) or hypersensitivity to any ingredient of the Investigational product
• 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)
• Pregnant or nursing women
• Women of childbearing potential who do not use proper contraception during the study
• Active liver disease; ALT or AST \> ULN x 2 at screening; or history of hepatic encephalopathy, esophageal varix, or portacaval shunt
• Receiving renal dialysis or history of kidney transplantation or presence of severe renal impairment (stage 4 or 5 chronic renal disease)

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (11)

Seoul National University Bundang Hospital

Seongnam-si, Bundang-gu, South Korea

Location

Inje University Busan Paik Hospital

Busan, Busanjin-gu, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, Dongjak-gu, South Korea

Location

Chonbuk National University Hospital

Jeonju, Jeonju-si, South Korea

Location

Kangbuk Samsung Hospital, Sungkyunkwan University

Seoul, Jongno-gu, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Location

Inje University Seoul Paik Hospital

Seoul, Jung-gu, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, Seodaemun-gu, South Korea

Location

Asan Medical Center

Seoul, Songpa-gu, South Korea

Location

Soon Chun Hyang University Hospital, Buchon

Bucheon-si, Wonmi-gu, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, Yangcheon-gu, South Korea

Location

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Interventions

ilaprazole

Condition Hierarchy (Ancestors)

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

Study Officials

• DongHo Lee, MD.PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A mulicenter, randomized, parallel, double blind, placebo-controlled

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 23, 2018
• Study Start: October 31, 2018
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (11)