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

Non-erosive Reflux Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444883
• Other study ID #: IL49NE03
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2018
• Est. completion date: February 25, 2020

Study information

• Verified date: December 2020
• Source: Il-Yang Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Non-erosive Reflux Disease

Intervention

Drug:
• Ilaprazole
10mgx2 tablet once daily for weeks

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital, Buchon	Bucheon	Wonmi-gu
Korea, Republic of	Inje University Busan Paik Hospital	Busan	Busanjin-gu
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeonju-si
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Bundang-gu
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul	Yangcheon-gu
Korea, Republic of	Inje University Seoul Paik Hospital	Seoul	Jung-gu
Korea, Republic of	Kangbuk Samsung Hospital, Sungkyunkwan University	Seoul	Jongno-gu
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul	Dongjak-gu
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul	Seodaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
Il-Yang Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4 weeks(28 days)
Secondary	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	4 weeks(28 days)
Secondary	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.	4 weeks(28 days)