Non-erosive Reflux DiseasePhase 3NCT03444883
Phase III Study to Evaluate Safety and Efficacy of Ilaprazole in Patients With NERD
A Phase 3 study testing Ilaprazole in people with Non-erosive Reflux Disease, run by Il-Yang Pharm. Co., Ltd. at 11 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Non-erosive Reflux Disease
- What is being tested?
- Ilaprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 277 participants
- Where
- 11 sitesSouth Korea
- Study dates
- 31 Oct 2018to 25 Feb 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 19 years and ≤ 80 years
- 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
- Voluntarily provide written informed consent to participate in this study
Who cannot join
- Esophageal stenosis, ulcerative stenosis, esophagogastric varices or Barrett esophagus confirmed by past upper gastrointestinal endoscopy within 1 year prior to screening
- Active peptic ulcer or gastrointestinal bleeding confirmed by past upper gastrointestinal endoscopy at screening or within 4 weeks prior to screening
- 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
- Clinically significant abnormal findings on ECG (major arrhythmia, multifocal PVC, second-degree or higher AV block, etc.) within 3 months prior to screening
- 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
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- Expected to continuously take nonsteroidal antiinflammatory drugs (NSAIDs) including aspirin or steroid preparations during the study
- 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
- Zollinger-Ellison syndrome; past history of alcoholism or drug abuse
- Past history of allergic symptoms (rash, fever, pruritus, etc.) or hypersensitivity to any ingredient of the Investigational product
- 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)
- Pregnant or nursing women
- Women of childbearing potential who do not use proper contraception during the study
- Active liver disease; ALT or AST > ULN x 2 at screening; or history of hepatic encephalopathy, esophageal varix, or portacaval shunt
- Receiving renal dialysis or history of kidney transplantation or presence of severe renal impairment (stage 4 or 5 chronic renal disease)
- Participated in another clinical study and took an investigational product within 3 months prior to screening
- Considered by the investigator to be ineligible to participate in this study for other reasons
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Soon Chun Hyang University Hospital, Buchon
Bucheon-si, Wonmi-gu
Inje University Busan Paik Hospital
Busan, Busanjin-gu
Chonbuk National University Hospital
Jeonju, Jeonju-si
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Dongjak-gu
Kangbuk Samsung Hospital, Sungkyunkwan University
Seoul, Jongno-gu
Seoul National University Hospital
Seoul, Jongno-gu
Inje University Seoul Paik Hospital
Seoul, Jung-gu
Severance Hospital Yonsei University Health System
Seoul, Seodaemun-gu
Asan Medical Center
Seoul, Songpa-gu
Ewha Womans University Mokdong Hospital
Seoul, Yangcheon-gu
About this study
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)
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
- Conditions
- Non-erosive Reflux Disease
- Being tested
- Ilaprazole
- Keywords
- NERD, PPI, Ilaprazole
- Medical subject headings
- Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlaprazoleDrug
Also called IY81149
10mgx2 tablet once daily for weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | 10mg Ilaprazole x 2 tablets Receives: Drug: Ilaprazole |
| Control Group | Placebo comparator | 10mg placebo of Ilaprazole x 2 tablets Receives: Drug: Ilaprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks(28 days)
Secondary outcomes (3)
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.
Measured: 4 weeks(28 days)
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
Measured: 4 weeks(28 days)
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.
Measured: 4 weeks(28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start31 Oct 2018
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A mulicenter, randomized, parallel, double blind, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DongHo Lee, MD.PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444883
- Sponsor's protocol ID
- IL49NE03
- Status last verified
- Dec 2020
- First submitted
- 19 Feb 2018
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03444883
- Acronym / sponsor ID
- IL49NE03
- Conditions
- Non-erosive Reflux Disease
- Keywords
- NERD, PPI, Ilaprazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is multicenter, randomized, parallel, double blind, placebo-controlled phase III study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A mulicenter, randomized, parallel, double blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Drug: Ilaprazole10mg Ilaprazole x 2 tablets |
| Control Group | Placebo comparator | Drug: Ilaprazole10mg placebo of Ilaprazole x 2 tablets |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged ≥ 19 years and ≤ 80 years
- 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
- Voluntarily provide written informed consent to participate in this study
Key exclusion criteria (17 listed)
- Esophageal stenosis, ulcerative stenosis, esophagogastric varices or Barrett esophagus confirmed by past upper gastrointestinal endoscopy within 1 year prior to screening
- Active peptic ulcer or gastrointestinal bleeding confirmed by past upper gastrointestinal endoscopy at screening or within 4 weeks prior to screening
- 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
- Clinically significant abnormal findings on ECG (major arrhythmia, multifocal PVC, second-degree or higher AV block, etc.) within 3 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IlaprazoleAlso: IY8114910mgx2 tablet once daily for weeks | Drug | Control Group, Treatment Group |
Primary outcome
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
3 secondary outcomes
Chang in esophagitis symptom score at 4 weeks of treatment vs pre-dose
Time frame: 4 weeks(28 days)
Change in PAGI-QoL score at 4 weeks of treatment vs pre-dose
Time frame: 4 weeks(28 days)
Change in esophagitis symptom score according to the maximum number of rescue medication doses per day
Time frame: 4 weeks(28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No. IPD will not be shared to other researchers.
Related trials for Non-erosive Reflux Disease
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Not yet recruiting
Mirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease
Non-Erosive Gastroesophageal Reflux Disease (NERD)
Not yet recruitingPhase 3
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis
Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)
Recruiting
QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease (The QUIET Trial)
Nocturnal Symptoms of GERD, Sleep Disorders in GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DongHo Lee, MD.PhD principal investigator
Seoul National University Bundang Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ilaprazole in people with Non-erosive Reflux Disease, run by Il-Yang Pharm. Co., Ltd. at 11 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of loss of esophagitis symptom at 4 weeks of treatment vs pre-dose (time frame: 4 weeks(28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.