Status Approved
First Submitted Date
2023/09/06
Registered Date
2023/10/27
Last Updated Date
2023/10/10
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0008892 |
|---|---|
| Unique Protocol ID | 2023-08-027 |
| Public/Brief Title | Investigator Initiated Trial to Evaluate the Efficacy of FEXUCLUE®40mg(Fexuprazan hydrochloride) in Patients with Iatrogenic Gastric Ulcer After Endoscopic Submucosal Dissection |
| Scientific Title | A Multi-center, Investigator Initiated Trial to Evaluate the Efficacy of FEXUCLUE®40mg(Fexuprazan hydrochloride) in Patients with Iatrogenic Gastric Ulcer After Endoscopic Submucosal Dissection |
| Acronym | JB_ESD_IIT01 |
| MFDS Regulated Study | Yes |
| IND/IDE Protocol | Yes |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status | Submitted pending |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | 2023-08-027 |
| Approval Date | 2023-09-19 |
| Institutional Review Board Name | jesushospital instituional Review Board |
| Institutional Review Board Address | 365, Seowon-ro, Wansan-gu, Jeonju-si, Jeollabuk-do |
| Institutional Review Board Telephone | 063-230-8845 |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Jin Woong cho |
| Title | director of gastrointestinal center |
| Telephone | +82-63-230-8114 |
| Affiliation | Presbyterian Medical Center |
| Address | 365, Seowon-ro, Wansan-gu, Jeonju-si, Jeollabuk-do |
| Contact Person for Public Queries | |
| Name | Jin Woong cho |
| Title | Professor |
| Telephone | +82-63-230-8114 |
| Affiliation | Presbyterian Medical Center |
| Address | 365, Seowon-ro, Wansan-gu, Jeonju-si, Jeollabuk-do |
| Contact Person for Updating Information | |
| Name | Jin Woong cho |
| Title | Professor |
| Telephone | +82-63-230-8114 |
| Affiliation | Presbyterian Medical Center |
| Address | 365, Seowon-ro, Wansan-gu, Jeonju-si, Jeollabuk-do |
4. Status
| Study Site | Multi-center Number of center : 2 | |
|---|---|---|
| Overall Recruitment Status | Not yet recruiting | |
| Date of First Enrollment | 2023-11-30 Anticipated | |
| Target Number of Participant | 105 | |
| Primary Completion Date | ||
| Study Completion Date | ||
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Wonkwang University Hospital | |
| Recruitment Status | Not yet recruiting | |
| Date of First Enrollment | 2023-11-30 , | |
| Recruitment Status by Participating Study Site 2 | ||
| Name of Study | Jeonbuk National University Hospital | |
| Recruitment Status | Not yet recruiting | |
| Date of First Enrollment | 2023-11-30 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Daewoong |
| Organization Type | Pharmaceutical Company |
| Project ID | JB_ESD_IIT01 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Presbyterian Medical Center |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | This clinical trial aims to evaluate the effectiveness and safety of patients with artificial ulcers caused by ESD by comparing the oral administration of Pexuclujeong®40mg once a day for 8 weeks with the oral administration of Esomeprazole 40mg once a day. As mentioned above, pexuprazan hydrochloride has the same treatment ability compared to esomeprazole, which is a PPI, and does not differ significantly in side effects, and has strengths in ease of use, gastric acid suppression, and retention time. In addition, faster and longer-term gastric acid suppression effects are likely to further promote the healing of artificial ulcers, reducing delayed bleeding after ESD. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Treatment |
| Phase | Not applicable |
| Intervention Model | Parallel |
| Blinding/Masking | Open |
| Allocation | RCT |
| Intervention Type | Drug |
| Intervention Description | The control group Nexium®40 mg was set to 40 mg once a day for general artificial ulcer treatment.Fexuclujeong®40mg, a clinical trial drug, was 40mg once a day in ERD, and the dose of this clinical trial was set to 40mg once a day by referring to this treatment dose. In addition, rebamipide 100 mg 1T Bid was added to both the test group and the control group to treat ulcers. In the case of the administration period, it is generally known that it takes 8 weeks to heal artificial ulcers after ESD, so it was decided to be 8 weeks by referring to other clinical trials. |
| Number of Arms | 2 |
| Arm 1 |
Arm Label experimental group |
|
Target Number of Participant 53 |
|
|
Arm Type Experimental |
|
|
Arm Description Fexuclue 40mg, 1T, 8 weeks |
|
| Arm 2 |
Arm Label Control group |
|
Target Number of Participant 52 |
|
|
Arm Type Active comparator |
|
|
Arm Description Nexium40mg, 1T, 8 weeks |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C16.2)Malignant neoplasm of body of stomach Patients with artificial gastric ulcers caused by ESD due to gastric cancer or hypothyroidism confined to mucous membranes |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 19Year~79Year |
|
|
Description ① Those who receive ESD due to gastric cancer or hypothyroidism confined to the mucous membrane |
|
| Exclusion Criteria |
① A person who is sensitive to the components of a clinical trial drug ② In the case of drugs that may affect the effectiveness of gastric acid secretion inhibitors as follows, those who took them within two weeks before endoscopic mucosal surgery - - PPI, H2 receptor antagonists, mucosal protective anti-ulcer drugs ③ Patients who are required to take combination of clinical trial drug licenses during the clinical trial period as follows - Combination inhibitors (atazanavir, nelpinavir, or lilphibirin-containing preparations, etc.) - Drugs that increase the risk of bleeding (such as aspirin, anti-coagulants, etc.) - - Steroid, NSAID ④ I've had surgery that can affect gastric acid secretion Let's. ⑤ Those who are unable to undergo upper gastrointestinal endoscopy (e.g., esophageal disease, gastrointestinal bleeding, etc ⑥ Endoscopic submucosal resection is prohibited (platelet reduction, coagulation disorder, etc.) ⑦ People with clinically significant liver and kidney disease ⑧ A person with a history of malignant tumors within three years (However, in the case of malignant tumors except for malignant tumors of the digestive system, those who have been cured and have passed more than 3 years without recurrence from the date of judgment can register.) ⑨ Person with bipolar disorder, anxiety disorder, panic disorder, physical form disorder, personality disorder, or other clinically significant psychiatric disorder ⑩ a person who is pregnant or lactating |
| Healthy Volunteers | No |
10. Outcome Measure(s)
| Type of Primary Outcome | Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Percentage of patients with endoscopic artificial ulcers turned into scars |
|
| Timepoint | Visit 3 |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Rate of delayed bleeding |
|
| Timepoint | After ESD |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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