Gastric CancerPhase 4NCT02638584
Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.
A Phase 4 study testing Ilaprazole and Rabeprazole in people with Gastric Cancer, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and investigated Prevention of gastrointestinal bleeding. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Ilaprazole and Rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to Mar 2018
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 year old ≤ Male or female < 85 year old
- Subject who underwent Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer
- Subject who agrees to participate and spontaneously sign the Informed consent form(ICF).
Who cannot join
- Known hypersensitivity to any component of ilaprazole
- Subjects who are taking contraindicated medications(ex. atazanavir) for experimental and concomitant drug.
- Subjects with abnormal levels in the laboratory tests
- Total Bilirubin, Creatinine> 1.5 times upper limit of normal
- Alanine transaminase(ALT), Aspartate transaminase(AST), Alkaline phosphatase, Blood urea nitrogen(BUN)> 2 times upper limit of normal
- Subjects diagnosed with other cancer within 5 years other than stomach cancer.
Show all 13Show fewer
- Subjects with a history of Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal strictures, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease
- Subjects with a history of major surgery that can affect gastric acid secretion.
- Subjects should continue taking the following medicine during the study period : anticholinergics, promoting motility agents, prostaglandin analogs, sucralfate, aspirin, steroid, NSAIDs drug
- Subjects with uncontrolled organ failure (liver dysfunction, renal dysfunction)
- Pregnant and/or lactating women
- Subjects participating in a clinical trial before another trial within 30 days
- Inconsistency judged subject by researcher
Trial locations and contacts
1 site in 1 country.
South Korea1 site
HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do
About this study
Official title: Effects of Ilaprazole 20mg on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone Endoscopic Submucosal Dissection(ESD) for Gastric Adenoma or Early Gastric Cancer.
This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and investigated Prevention of gastrointestinal bleeding.
Read the detailed description
This study is a Multicenter, Randomized, Parallel and Prospective study to compare Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and to investigate Prevention of gastrointestinal bleeding.
Participants are defined as persons who underwent a Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer. For 8 weeks, Participants treated as Ilaprazole 20mg or Rabeprazole 20mg once a day. After treatment, The ulcer healing rate was evaluated by Endoscopy at 4, 8 weeks.
- Conditions
- Gastric Cancer
- Being tested
- Ilaprazole, Rabeprazole
- Keywords
- Ilaprazole, Gastric Adenoma, Early Gastric Cancer, Endoscopic Submucosal Dissection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlaprazoleDrug
Also called Ilaprazole(Noltec®)
Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast
RabeprazoleDrug
Also called Pariet®
Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast
| Study group | Role | What they receive |
|---|---|---|
| Ilaprazole | Experimental | Ilaprazole tab 10mg, 2 tablets once daily for 8 weeks. Receives: Drug: Ilaprazole |
| Rabeprazole | Active comparator | Rabeprazole tab 20mg, 1 tablet once daily for 8 weeks. Receives: Drug: Rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ulcer healing rate after endoscopic submucosal dissection
Measured: participants will be followed at 8 weeks
Secondary outcomes (3)
The rate of Ulcer size reduction as assessed by measurements of ulcer size change.
The rate of Ulcer size reduction(Δ) : [(Initial ulcer size) - (Ulcer size at 8 weeks)] / (Initial ulcer size)
Measured: at 8 weeks after treatment
The quality of ulcer healing as evaluated by the observation of investigator at tracking endoscopy.
Apply 0.15% Indigo carmine to scarring of the ulcer and Describe the pattern of the scar as flat, nodular or intermediate at tracking endoscopy.
Measured: at 8 weeks after treatment
The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire.
The Korean Gastrointestinal Symptom Rating Scale questionnaire measured the patient's symptom degree.
Measured: at 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ChangSeok Bang, MD, PhD, Principal investigator, HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638584
- Sponsor's protocol ID
- HUMC-ILA01
- Status last verified
- Aug 2018
- First submitted
- 14 Dec 2015
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: not yet decided
Publications
Bang CS, Shin WG, Seo SI, Choi MH, Jang HJ, Park SW, Kae SH, Yang YJ, Shin SP, Baik GH, Kim HY. Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study. Surg Endosc. 2019 May;33(5):1376-1385. doi: 10.1007/s00464-018-6412-9. Epub 2018 Aug 30.
PubMed 30167954
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ilaprazole 20mg on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone Endoscopic Submucosal Dissection(ESD) for Gastric Adenoma or Early Gastric Cancer.
- ClinicalTrials.gov ID
- NCT02638584
- Acronym / sponsor ID
- HUMC-ILA01
- Conditions
- Gastric Cancer
- Keywords
- Ilaprazole, Gastric Adenoma, Early Gastric Cancer, Endoscopic Submucosal Dissection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 23 Dec 2015 (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.
This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and investigated Prevention of gastrointestinal bleeding.
Detailed description
This study is a Multicenter, Randomized, Parallel and Prospective study to compare Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and to investigate Prevention of gastrointestinal bleeding.
Participants are defined as persons who underwent a Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer. For 8 weeks, Participants treated as Ilaprazole 20mg or Rabeprazole 20mg once a day. After treatment, The ulcer healing rate was evaluated by Endoscopy at 4, 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ilaprazole | Experimental | Drug: IlaprazoleIlaprazole tab 10mg, 2 tablets once daily for 8 weeks. |
| Rabeprazole | Active comparator | Drug: RabeprazoleRabeprazole tab 20mg, 1 tablet once daily for 8 weeks. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 year old ≤ Male or female < 85 year old
- Subject who underwent Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer
- Subject who agrees to participate and spontaneously sign the Informed consent form(ICF).
Key exclusion criteria (13 listed)
- Known hypersensitivity to any component of ilaprazole
- Subjects who are taking contraindicated medications(ex. atazanavir) for experimental and concomitant drug.
- Subjects with abnormal levels in the laboratory tests
- Subjects diagnosed with other cancer within 5 years other than stomach cancer.
- Subjects with a history of Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal strictures, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease
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: Ilaprazole(Noltec®)Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast | Drug | Ilaprazole |
| RabeprazoleAlso: Pariet®Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast | Drug | Rabeprazole |
Primary outcome
The Ulcer healing rate after endoscopic submucosal dissection
Time frame: participants will be followed at 8 weeks
3 secondary outcomes
The rate of Ulcer size reduction as assessed by measurements of ulcer size change.
Time frame: at 8 weeks after treatment
The quality of ulcer healing as evaluated by the observation of investigator at tracking endoscopy.
Time frame: at 8 weeks after treatment
The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire.
Time frame: at 8 weeks after treatment
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 31 Jul 2020.
- Derived from this study: PubMed 30167954Bang CS, Shin WG, Seo SI, Choi MH, Jang HJ, Park SW, Kae SH, Yang YJ, Shin SP, Baik GH, Kim HY. Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study. Surg Endosc. 2019 May;33(5):1376-1385. doi: 10.1007/s00464-018-6412-9. Epub 2018 Aug 30.
- Individual participant dataSharing planned: Undecided. not yet decided
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
ChangSeok Bang, MD, PhD principal investigator
HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital
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 and Rabeprazole in people with Gastric Cancer, run by Il-Yang Pharm. Co., Ltd. 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 3 inclusion and 13 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 31 Jul 2020. 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?
The Ulcer healing rate after endoscopic submucosal dissection (time frame: participants will be followed at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02638584, which also lists 1 linked publication.
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 31 Jul 2020.