Gastrointestinal Subepithelial TumorsPhase 4NCT02666976
The Prospective Study on the Effect of Ilaprazole in Non-erosive Reflux Disease Patients; Focused on Histologic Findings and Inflammatory Biomarker
A Phase 4 study testing Ilaprazole in people with Gastrointestinal Subepithelial Tumors, run by Yonsei University at 1 site in South Korea.
Trial summary
Non-erosive reflux disease (NERD) patients used to be less responsive to proton pump inhibitor (PPI)s as compared with patients with erosive esophagitis. The aim of this study is to objectively evaluate the effect of a new PPI, ilaprazole in NERD for adjusting the focus of symptom score, histopathologic findings and… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastrointestinal Subepithelial Tumors
- What is being tested?
- Ilaprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Jan 2016
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 20 years old and younger than 80 years old
- Patients with typical reflux symptoms at least 2days per week (or GERD Q score ≥ 8 )
- No erosion at GE junction through endoscopy
- Patients that can perform a 24 hr - combined multichannel intraluminal impedance and pH esophageal monitoring prior to this study.
Who cannot join
- included prior history of documented intolerance of ilaprazole or similar PPIs, or
- unsuspected alarm symptoms such as weight loss, hematemesis, hematochezia, jaundice or other significant illness like malignancy
- alcoholism or drug addiction
- uncontrolled diabetes, cerebrovascular accident or diseases needed an operation in the last 3 months before enrollment
- any previous esophageal surgery
- malignancy in gastrointestinal tract within 5years
Show all 11Show fewer
- pregnant woman
- Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal stricture, duodenal ulcer, gastric ulcer, pancreatitis, absorption disorder, severe cardiovascular disease, severe lung disease in the last 3 months before enrollment
- history of steadily taking medicine such as diazepam, quinidine, diphenylhydantoin, mephenytoin, warfarin, anticholinergic, prostaglandin analog, antineoplastic agent, salicylate, steroid, pro-motility drug, nonsteroidal anti-inflammatory drugs(NSAIDS)
- patients who were registered other exams within 28days
- patients who could not conduct sedated endoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Non-erosive reflux disease (NERD) patients used to be less responsive to proton pump inhibitor (PPI)s as compared with patients with erosive esophagitis. The aim of this study is to objectively evaluate the effect of a new PPI, ilaprazole in NERD for adjusting the focus of symptom score, histopathologic findings and inflammatory biomarker.
A prospective study performed at single hospital enrolled 20 patients who were diagnosed clinically as NERD. Patients underwent EGD, a 24hr-combined multichannel intraluminal impedance and pH esophageal monitoring (MII-pH) and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) will be accessed.
- Conditions
- Gastrointestinal Subepithelial Tumors
- Being tested
- Ilaprazole
- Keywords
- Gastroesophageal reflux, proton pump inhibitors, ilaprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlaprazoleDrug
Patients who were diagnosed clinically as NERD and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were accessed.
| Study group | Role | What they receive |
|---|---|---|
| ilaprazole group | Experimental | ilaprazole 20mg once daily for 4 weeks. Receives: Drug: Ilaprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of symptoms
All patients complete the GerdQ questionnaire before and after taking ilaprazole. It was utilized to assess improvement of symptoms after taking medicine.
Measured: 4 weeks
Secondary outcomes (2)
changes of histopathological findings
Changes of histopathological findings and inflammatory biomarkers will be assessed before and after treatment. Histologic findings include basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte. Inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were also accessed by RT-PCR.
Measured: 4 weeks
changes of inflammatory biomarkers
Changes of histopathological findings and inflammatory biomarkers will be assessed before and after treatment. Histologic findings include basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte. Inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were also accessed by RT-PCR.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJul 2014
- Primary completionAug 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Subepithelial TumorsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666976
- Sponsor's protocol ID
- 4-2014-0110
- Status last verified
- Jan 2016
- First submitted
- 24 Jan 2016
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Study on the Effect of Ilaprazole in Non-erosive Reflux Disease Patients; Focused on Histologic Findings and Inflammatory Biomarker
- ClinicalTrials.gov ID
- NCT02666976
- Acronym / sponsor ID
- 4-2014-0110
- Conditions
- Gastrointestinal Subepithelial Tumors
- Keywords
- Gastroesophageal reflux, proton pump inhibitors, ilaprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Jan 2016 (estimated)
- 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.
Non-erosive reflux disease (NERD) patients used to be less responsive to proton pump inhibitor (PPI)s as compared with patients with erosive esophagitis. The aim of this study is to objectively evaluate the effect of a new PPI, ilaprazole in NERD for adjusting the focus of symptom score, histopathologic findings and inflammatory biomarker.
A prospective study performed at single hospital enrolled 20 patients who were diagnosed clinically as NERD. Patients underwent EGD, a 24hr-combined multichannel intraluminal impedance and pH esophageal monitoring (MII-pH) and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) will be accessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ilaprazole group | Experimental | Drug: Ilaprazoleilaprazole 20mg once daily for 4 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 20 years old and younger than 80 years old
- Patients with typical reflux symptoms at least 2days per week (or GERD Q score ≥ 8 )
- No erosion at GE junction through endoscopy
- Patients that can perform a 24 hr - combined multichannel intraluminal impedance and pH esophageal monitoring prior to this study.
Key exclusion criteria (11 listed)
- included prior history of documented intolerance of ilaprazole or similar PPIs, or
- unsuspected alarm symptoms such as weight loss, hematemesis, hematochezia, jaundice or other significant illness like malignancy
- alcoholism or drug addiction
- uncontrolled diabetes, cerebrovascular accident or diseases needed an operation in the last 3 months before enrollment
- any previous esophageal surgery
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 |
|---|---|---|
| IlaprazolePatients who were diagnosed clinically as NERD and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were accessed. | Drug | ilaprazole group |
Primary outcome
Changes of symptoms
Time frame: 4 weeks
All patients complete the GerdQ questionnaire before and after taking ilaprazole. It was utilized to assess improvement of symptoms after taking medicine.
2 secondary outcomes
changes of histopathological findings
Time frame: 4 weeks
changes of inflammatory biomarkers
Time frame: 4 weeks
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 22 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Subepithelial Tumors
RecruitingObservational study
Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry
Subepithelial Gastrointestinal Tumors, Adenoma
Not yet recruitingObservational study
Role of Endoscopic Ultrasound Elastography in Diagnosis of Gastrointestinal Subepithelial and Mediastinal Lesions
Mediastinal ( Chest) Masses, Gastrointestinal Subepithelial Tumors
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ilaprazole in people with Gastrointestinal Subepithelial Tumors, run by Yonsei University at 1 site 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 11 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Changes of symptoms (time frame: 4 weeks). 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 22 Mar 2019.