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A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients With Gastric Ulcer

Primary Purpose

Gastric Ulcer

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HIP0612
HPP2202
RLD2204
HPP2201
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Ulcer

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 19 years to 75 years Diagnosis of active gastric ulcers according to the Sakita-Miwa classification from upper GI endoscopy Patients understood the consents and purpose of this trial and signed consent form Exclusion Criteria: Patients who cannot perform endoscopy Finding of malignancy, duodenal ulcer, ulcer perforation, postoperative (eg, endoscopic mucosal resection, endoscopic submucosal dissection) ulcer(s), Barrett's oesophagus measuring >3cm, oesophageal dysplasia, oesophageal and/or gastric varices, bleeding disorder on upper GI endoscopy History of definitive acid lowering surgery or pervious oesophageal or gastric surgery (except for benign tumor excisionn, simple close of perforations) Zollinger-Ellison syndrome, pyloric stenosis, oesophageal motility disorder, esophageal stricture Severe hepatic disease Severe renal disease, CKD Bleeding disorder History of malignancy or was treated for malignancy within 5 years before the start of the Visit 1 Patients who have taken drugs containing following list within 2 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: acid suppressive drugs, antacids, anticholinergic drugs, gastroprotective agent Patients who have taken drugs containing following list within 1 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: antithrombotic agents, NSAIDs, aspirin Requirement of use of excluded medications during the study History of allergic reaction to the medications used in this study Glucose-galactose malabsorption, Fructose intolerance, Sucrase-isomaltase deficiency Use of other investigational drugs within 30 days prior to the study History of alcohol or drug abuse Positive to pregnancy test, nursing mother, intention on pregnancy Considered by investigator as not appropriate to participate in the clinical study with other reason

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    HIP0612

    RLD2204

    Arm Description

    Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.

    Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.

    Outcomes

    Primary Outcome Measures

    Healing rate of gastric ulcer
    Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study

    Secondary Outcome Measures

    Healing rate of gastric ulcer
    Healing rate of gastric ulcer according to H.pylori infection status
    Post-treatment resolution rate of GI symptoms

    Full Information

    First Posted
    December 9, 2022
    Last Updated
    December 20, 2022
    Sponsor
    Hanmi Pharmaceutical Company Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05656092
    Brief Title
    A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients With Gastric Ulcer
    Official Title
    A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of HIP0612 in Patients With Gastric Ulcer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hanmi Pharmaceutical Company Limited

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Ulcer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    226 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HIP0612
    Arm Type
    Experimental
    Arm Description
    Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.
    Arm Title
    RLD2204
    Arm Type
    Active Comparator
    Arm Description
    Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    HIP0612
    Intervention Description
    Test drug
    Intervention Type
    Drug
    Intervention Name(s)
    HPP2202
    Intervention Description
    Placebo drug
    Intervention Type
    Drug
    Intervention Name(s)
    RLD2204
    Intervention Description
    Reference drug
    Intervention Type
    Drug
    Intervention Name(s)
    HPP2201
    Intervention Description
    Placebo drug
    Primary Outcome Measure Information:
    Title
    Healing rate of gastric ulcer
    Description
    Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study
    Time Frame
    week 8
    Secondary Outcome Measure Information:
    Title
    Healing rate of gastric ulcer
    Time Frame
    week 4
    Title
    Healing rate of gastric ulcer according to H.pylori infection status
    Time Frame
    week 4, 8
    Title
    Post-treatment resolution rate of GI symptoms
    Time Frame
    week 4, 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 19 years to 75 years Diagnosis of active gastric ulcers according to the Sakita-Miwa classification from upper GI endoscopy Patients understood the consents and purpose of this trial and signed consent form Exclusion Criteria: Patients who cannot perform endoscopy Finding of malignancy, duodenal ulcer, ulcer perforation, postoperative (eg, endoscopic mucosal resection, endoscopic submucosal dissection) ulcer(s), Barrett's oesophagus measuring >3cm, oesophageal dysplasia, oesophageal and/or gastric varices, bleeding disorder on upper GI endoscopy History of definitive acid lowering surgery or pervious oesophageal or gastric surgery (except for benign tumor excisionn, simple close of perforations) Zollinger-Ellison syndrome, pyloric stenosis, oesophageal motility disorder, esophageal stricture Severe hepatic disease Severe renal disease, CKD Bleeding disorder History of malignancy or was treated for malignancy within 5 years before the start of the Visit 1 Patients who have taken drugs containing following list within 2 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: acid suppressive drugs, antacids, anticholinergic drugs, gastroprotective agent Patients who have taken drugs containing following list within 1 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: antithrombotic agents, NSAIDs, aspirin Requirement of use of excluded medications during the study History of allergic reaction to the medications used in this study Glucose-galactose malabsorption, Fructose intolerance, Sucrase-isomaltase deficiency Use of other investigational drugs within 30 days prior to the study History of alcohol or drug abuse Positive to pregnancy test, nursing mother, intention on pregnancy Considered by investigator as not appropriate to participate in the clinical study with other reason
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Minsook Jung
    Phone
    +82)-2-410-0442
    Ext
    0442
    Email
    jungms@hanmi.co.kr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients With Gastric Ulcer

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