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Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding (CEGP003)

Primary Purpose

Peptic Ulcer Bleeding

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CEGP003
Injection Tx
Sponsored by
CGBio Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer Bleeding focused on measuring Bleeding

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)

Exclusion Criteria:

  • Subjects who have a history of malignant tumor in upper gastro-intestinal site
  • Subjects with platelet and coagulation dysfunction (PLT < 50E9/L, INR > 2)
  • Subjects that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 72 hours after the treatment
  • Subjects with one or more bleeding sources
  • Subjects who are pregnant or breast-feeding
  • Subject who are allergic or have a hypersensitive reaction to Hydroxyethyl-cellulose or EGF
  • Subjects who have undergone endoscopically therapies within the last 7 days
  • Subjects who are considered not suitable for the study by significant disease
  • Subjects who are not able to comply with the study requirements
  • Subjects who are currently enrolled in another clinical study which can impact the study within 30 days of screening
  • Subjects who are considered not suitable for the study by the investigator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CEGP003

    Injection Tx

    Arm Description

    Outcomes

    Primary Outcome Measures

    Initial hemostasis rate
    Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.

    Secondary Outcome Measures

    Recurrent bleeding rate
    If any of the following conditions are met, an endoscopy will verify for rebleeding. Associated with overt signs of GI bleed (melena, and/or hematemesis) Instability of Vital signs (<80/60 mmHg of blood pressure, and/or >120 beats/min of pulse) Decrease in hemoglobin of at least 2 g/dl after Initial hemostasis bleeding can be confirmed directly (direct visualization)
    Time required for treatment
    The time from when the endoscope is inserted to when the endoscope treatment is completed.
    Wound healing effect of peptic ulcer
    Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.
    Usability for the delivery system
    Evaluation of success for the delivery system

    Full Information

    First Posted
    March 5, 2018
    Last Updated
    March 16, 2018
    Sponsor
    CGBio Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03469167
    Brief Title
    Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding
    Acronym
    CEGP003
    Official Title
    Clinical Study to Evaluate Efficacy and Safety of "CEGP003(Wound Dressing Solution Containing EGF)" for Achieving Hemostasis and Protecting Ulcer in Patients With Acute Peptic Ulcer Bleeding: A Prospective, Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 15, 2014 (Actual)
    Primary Completion Date
    November 10, 2015 (Actual)
    Study Completion Date
    January 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CGBio Inc.

    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
    This is a prospective, single-blinded, randomized study to evaluate the efficacy and safety of CEGP003 in patients with acute peptic ulcers bleeding, compared to endoscopic epinephrine injection therapy.
    Detailed Description
    CEGP003 is wound dressing solution containing Hydroxyethyl-cellulose and EGF. Epidermal growth factor (EGF) stimulates cell growth and differentiation by binding to its receptor, which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a peptic ulcers bleeding.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peptic Ulcer Bleeding
    Keywords
    Bleeding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CEGP003
    Arm Type
    Experimental
    Arm Title
    Injection Tx
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    CEGP003
    Other Intervention Name(s)
    EGF
    Intervention Description
    Application of CEGP003 to peptic ulcer bleeding
    Intervention Type
    Device
    Intervention Name(s)
    Injection Tx
    Other Intervention Name(s)
    epinephrine injection
    Intervention Description
    Injection of epinephrine to peptic ulcer bleeding
    Primary Outcome Measure Information:
    Title
    Initial hemostasis rate
    Description
    Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.
    Time Frame
    Within 10 minutes after first endoscopy session
    Secondary Outcome Measure Information:
    Title
    Recurrent bleeding rate
    Description
    If any of the following conditions are met, an endoscopy will verify for rebleeding. Associated with overt signs of GI bleed (melena, and/or hematemesis) Instability of Vital signs (<80/60 mmHg of blood pressure, and/or >120 beats/min of pulse) Decrease in hemoglobin of at least 2 g/dl after Initial hemostasis bleeding can be confirmed directly (direct visualization)
    Time Frame
    Within 72 hours
    Title
    Time required for treatment
    Description
    The time from when the endoscope is inserted to when the endoscope treatment is completed.
    Time Frame
    0 day
    Title
    Wound healing effect of peptic ulcer
    Description
    Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.
    Time Frame
    After 3 days (72 hours)
    Title
    Usability for the delivery system
    Description
    Evaluation of success for the delivery system
    Time Frame
    0 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB) Exclusion Criteria: Subjects who have a history of malignant tumor in upper gastro-intestinal site Subjects with platelet and coagulation dysfunction (PLT < 50E9/L, INR > 2) Subjects that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 72 hours after the treatment Subjects with one or more bleeding sources Subjects who are pregnant or breast-feeding Subject who are allergic or have a hypersensitive reaction to Hydroxyethyl-cellulose or EGF Subjects who have undergone endoscopically therapies within the last 7 days Subjects who are considered not suitable for the study by significant disease Subjects who are not able to comply with the study requirements Subjects who are currently enrolled in another clinical study which can impact the study within 30 days of screening Subjects who are considered not suitable for the study by the investigator
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Don Haeng Lee, MD. PhD.
    Organizational Affiliation
    Inha University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Su Jin Hong, MD. PhD.
    Organizational Affiliation
    Soon Chun Hyang University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding

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