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

• Sponsor: Il-Yang Pharm. Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03444883
• Collaborator: (none)
• Enrollment: 277
• Locations: 11
• Arms: 2
• Actual Duration (Months): 15.8
• Patients Per Site: 25.2
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 277 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A mulicenter, randomized, parallel, double blind, placebo-controlledA 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)
• Actual Study Start Date: Oct 31, 2018
• Actual Primary Completion Date: Feb 25, 2020
• Actual Study Completion Date: Feb 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment Group 10mg Ilaprazole x 2 tablets	Drug: Ilaprazole; 10mgx2 tablet once daily for weeks; Other Names: IY81149
Placebo Comparator: Control Group 10mg placebo of Ilaprazole x 2 tablets	Drug: Ilaprazole; 10mgx2 tablet once daily for weeks; Other Names: IY81149

Outcome Measures

Primary Outcome Measures

1. Rate of loss of esophagitis symptom at 4 weeks of treatment vs pre-dose [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 [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 [4 weeks(28 days)]

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: 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

1. 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

1. Clinically significant abnormal findings on ECG (major arrhythmia, multifocal PVC, second-degree or higher AV block, etc.) within 3 months prior to screening

2. 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

3. Expected to continuously take nonsteroidal antiinflammatory drugs (NSAIDs) including aspirin or steroid preparations during the study

4. 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

5. Zollinger-Ellison syndrome; past history of alcoholism or drug abuse

6. Past history of allergic symptoms (rash, fever, pruritus, etc.) or hypersensitivity to any ingredient of the Investigational product

7. 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)

8. Pregnant or nursing women

9. Women of childbearing potential who do not use proper contraception during the study

10. Active liver disease; ALT or AST > ULN x 2 at screening; or history of hepatic encephalopathy, esophageal varix, or portacaval shunt

11. Receiving renal dialysis or history of kidney transplantation or presence of severe renal impairment (stage 4 or 5 chronic renal disease)

12. Participated in another clinical study and took an investigational product within 3 months prior to screening

13. Considered by the investigator to be ineligible to participate in this study for other reasons

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Bundang-gu	Korea, Republic of
2	Inje University Busan Paik Hospital	Busan	Busanjin-gu	Korea, Republic of
3	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul	Dongjak-gu	Korea, Republic of
4	Chonbuk National University Hospital	Jeonju	Jeonju-si	Korea, Republic of
5	Kangbuk Samsung Hospital, Sungkyunkwan University	Seoul	Jongno-gu	Korea, Republic of
6	Seoul National University Hospital	Seoul	Jongno-gu	Korea, Republic of
7	Inje University Seoul Paik Hospital	Seoul	Jung-gu	Korea, Republic of
8	Severance Hospital Yonsei University Health System	Seoul	Seodaemun-gu	Korea, Republic of
9	Asan Medical Center	Seoul	Songpa-gu	Korea, Republic of
10	Soon Chun Hyang University Hospital, Buchon	Bucheon	Wonmi-gu	Korea, Republic of
11	Ewha Womans University Mokdong Hospital	Seoul	Yangcheon-gu	Korea, Republic of

Sponsors and Collaborators

• Il-Yang Pharm. Co., Ltd.

Investigators

• Principal Investigator: DongHo Lee, MD.PhD, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Il-Yang Pharm. Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03444883
• Other Study ID Numbers: IL49NE03
• First Posted: Feb 23, 2018
• Last Update Posted: Jan 5, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Il-Yang Pharm. Co., Ltd.: NERD; PPI; Ilaprazole
• Additional relevant MeSH terms: Gastroesophageal Reflux

Study Results

No Results Posted as of Jan 5, 2021