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

Last updated: December 30, 2020
Sponsor: Il-Yang Pharm. Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT03444883
IL49NE03
  • Ages 19-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 3months before screening 2-2) Have experienced at least either heartburn or acidregurgitation of moderate or higher intensity on at least 2 days of 7 days prior toinitiation of the investigational product 2-3) Esophageal mucosal breaks by LAClassification are not observed on upper gastrointestinal endoscopy at screening
  3. Voluntarily provide written informed consent to participate in this study

Exclusion

Exclusion Criteria:

  1. Esophageal stenosis, ulcerative stenosis, esophagogastric varices or Barrett esophagusconfirmed by past upper gastrointestinal endoscopy within 1 year prior to screening
  2. Active peptic ulcer or gastrointestinal bleeding confirmed by past uppergastrointestinal 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) AlkalinePhosphatase, 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, mucosalprotective drugs, prokinetics, etc. within 2 weeks prior to initiation of theinvestigational product administration, or has taken PPIs within 4 weeks prior toinitiation of the investigational product administration
  6. Expected to continuously take nonsteroidal antiinflammatory drugs (NSAIDs) includingaspirin 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: historyof major gastrointestinal surgery such as gastrectomy, gastroenterostomy, colectomy,gastric bypass, gastric ligation or gastric banding; presence or history of activeinflammatory bowel disease within 12 months prior to screening; has undergone criticalsurgery that may influence gastric acid secretion with exception of surgeries such asappendectomy, 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 toany ingredient of the Investigational product
  10. Past history of treated or untreated malignancy, with or without local recurrence ormetastasis, within 5 years prior to screening (with exception of local basal cellcarcinoma 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 hepaticencephalopathy, esophageal varix, or portacaval shunt
  14. Receiving renal dialysis or history of kidney transplantation or presence of severerenal impairment (stage 4 or 5 chronic renal disease)
  15. Participated in another clinical study and took an investigational product within 3months prior to screening
  16. Considered by the investigator to be ineligible to participate in this study for otherreasons

Study Design

Total Participants: 277
Study Start date:
October 31, 2018
Estimated Completion Date:
February 25, 2020

Study Description

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

Connect with a study center

  • Seoul National University Bundang Hospital

    Seongnam-si, Bundang-gu
    Korea, Republic of

    Site Not Available

  • Inje University Busan Paik Hospital

    Busan, Busanjin-gu
    Korea, Republic of

    Site Not Available

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, Dongjak-gu
    Korea, Republic of

    Site Not Available

  • Chonbuk National University Hospital

    Jeonju, Jeonju-si
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital, Sungkyunkwan University

    Seoul, Jongno-gu
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Jongno-gu
    Korea, Republic of

    Site Not Available

  • Inje University Seoul Paik Hospital

    Seoul, Jung-gu
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, Seodaemun-gu
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, Songpa-gu
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital, Buchon

    Bucheon, Wonmi-gu
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Mokdong Hospital

    Seoul, Yangcheon-gu
    Korea, Republic of

    Site Not Available

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