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出境医 / 临床实验 / Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis
Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis
Study Description
Brief Summary:
This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healed Erosive Esophagitis | Drug: Tegoprazan 25mg QD Drug: Lansoprazole 15mg QD | Phase 3 |
Detailed Description:
This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 318 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis |
| Actual Study Start Date : | June 18, 2019 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Tegoprazan 25mg QD
Tegoprazan 25mg tablet, once daily, oral administration
|
Drug: Tegoprazan 25mg QD
Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.
|
|
Active Comparator: Lansoprazole 15mg QD
Lansoprazole 15mg capsule, once daily, oral administration
|
Drug: Lansoprazole 15mg QD
Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.
|
Outcome Measures
Primary Outcome Measures :
- Endoscopic remission rate of EE at 24-week [ Time Frame: 24-week ]Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)
Secondary Outcome Measures :
- Endoscopic remission rate of EE at 12-week [ Time Frame: 12-week ]Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks)
Eligibility Criteria
| Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
- Healed erosive esophagitis within 7 days prior to Randomization
- No heartburn and regurgitation within 7 days prior to Randomization
Exclusion Criteria:
- Unable to undergo upper GI endoscopy
- Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with >3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy
- Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
- History of acid-suppressive, esophageal or gastric surgeries
Contacts and Locations
Contacts
| Contact: Hee Hyun Kim | 82-2-6477-0258 | heehyun.kim@kolmar.co.kr | |
| Contact: Min Ja Kang | 82-2-6477-0260 | minja.kang@kolmar.co.kr |
Locations
| Korea, Republic of | |
| Hanyang University Seoul Hospital | Recruiting |
| Seoul, Korea, Republic of, 133-792 | |
Sponsors and Collaborators
HK inno.N Corporation
Investigators
| Principal Investigator: | Oh Young Lee, Ph.D | Hanyang University Seoul Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 14, 2019 | ||||||||
| First Posted Date ICMJE | July 16, 2019 | ||||||||
| Last Update Posted Date | July 16, 2019 | ||||||||
| Actual Study Start Date ICMJE | June 18, 2019 | ||||||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Endoscopic remission rate of EE at 24-week [ Time Frame: 24-week ] Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Endoscopic remission rate of EE at 12-week [ Time Frame: 12-week ] Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks)
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis | ||||||||
| Official Title ICMJE | A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis | ||||||||
| Brief Summary | This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months. | ||||||||
| Detailed Description | This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg). | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Healed Erosive Esophagitis | ||||||||
| Intervention ICMJE |
|
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| Study Arms ICMJE |
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
318 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2020 | ||||||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 20 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Korea, Republic of | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04022096 | ||||||||
| Other Study ID Numbers ICMJE | CJ_APA_305 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | HK inno.N Corporation | ||||||||
| Study Sponsor ICMJE | HK inno.N Corporation | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | HK inno.N Corporation | ||||||||
| Verification Date | July 2019 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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