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

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ClinicalTrials.gov Identifier: NCT03444883
Recruitment Status : Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 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)
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Active Comparator: Treatment Group
10mg Ilaprazole x 2 tablets
Drug: Ilaprazole
10mgx2 tablet once daily for weeks

Placebo Comparator: Control Group
10mg placebo of Ilaprazole x 2 tablets
Drug: Ilaprazole
10mgx2 tablet once daily for weeks




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



Information from the National Library of Medicine

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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, Barrett esophagus, active peptic ulcer, gastrointestinal bleeding, or malignancy confirmed by past upper gastrointestinal endoscopy
  2. Abnormal value on laboratory test at screening:
  3. Clinically significant abnormal findings on ECG (major arrhythmia, multifocal PVC, second-degree or higher AV block, etc.) within 3 months prior to screening
  4. Have taken H2 receptor antagonists (H2RA), prostaglandin preparations, mucosal protective drugs, prokinetics, etc. at usual dosage within 2 weeks prior to initiation of the investigational product, or has taken PPIs at usual dosage within 4 weeks prior to initiation of the investigational product
  5. Expected to continuously take nonsteroidal antiinflammatory drugs (NSAIDs) including aspirin (≥ 325 mg/day) or steroid preparations during the study
  6. 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
  7. Zollinger-Ellison syndrome; past history of alcoholism or drug abuse
  8. Past history of allergic symptoms (rash, fever, pruritus, etc.) or hypersensitivity to any ingredient of the study drug
  9. 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)
  10. Pregnant or nursing women
  11. Women of childbearing potential who do not use proper contraception during the study
  12. Active liver disease; ALT or AST > ULN x 2 at screening; or history of hepatic encephalopathy, esophageal varix, or portacaval shunt
  13. Receiving renal dialysis or history of kidney transplantation or presence of severe renal impairment (stage 4 or 5 chronic renal disease)
  14. Participated in another clinical study and took an investigational product within 3 months prior to screening
  15. Considered by the investigator to be ineligible to participate in this study for other reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444883


Contacts
Contact: DongHo Lee, MD.PhD +82-31-787-7000 dhljohn@yahoo.co.kr

Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.

Responsible Party: Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03444883     History of Changes
Other Study ID Numbers: IL49NE03
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases