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CompletedNCT03444883Updated Jan 5, 2021

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

A Phase 3 interventional study of Ilaprazole in Non-erosive Reflux Disease, sponsored by Il-Yang Pharm. Co., Ltd.. Completed at 11 sites in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by Il-Yang Pharm. Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
277
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

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.

Read the detailed description

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

02

Conditions studied

  • Non-erosive Reflux Disease

Keywords

  • NERD
  • PPI
  • Ilaprazole
03

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
277 participants (actual)

Study arms

  • Active comparator
    Treatment Group

    10mg Ilaprazole x 2 tablets

    Drug: Ilaprazole

  • Placebo comparator
    Control Group

    10mg placebo of Ilaprazole x 2 tablets

    Drug: Ilaprazole

Interventions

  • DrugIlaprazole

    10mgx2 tablet once daily for weeks

    Also known as: IY81149

05

What researchers measure

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

    Time frame: 4 weeks(28 days)

Secondary outcomes

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

    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.

    Time frame: 4 weeks(28 days)

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

    The change in mean score for quality of life assessed with PAGI-QoL

    Time frame: 4 weeks(28 days)

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

    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.

    Time frame: 4 weeks(28 days)

06

Study locations

11 sites
  • 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
07

References and documents

Individual participant data

Plan to share: No — IPD will not be shared to other researchers.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03444883
Lead sponsor
Il-Yang Pharm. Co., Ltd.
Responsible party
Sponsor
First posted
Feb 23, 2018
Start date
Oct 31, 2018
Primary completion
Feb 25, 2020
Completion
Feb 25, 2020
Last update
Jan 5, 2021

Study contacts

DongHo Lee, MD.PhD
principal investigator · Seoul National University Bundang Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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