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

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ClinicalTrials.gov Identifier: NCT03469167
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
CGBio Inc.

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.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Bleeding Device: CEGP003 Device: Injection Tx Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2014
Actual Primary Completion Date : November 10, 2015
Actual Study Completion Date : January 2, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Epinephrine

Arm Intervention/treatment
Experimental: CEGP003 Device: CEGP003
Application of CEGP003 to peptic ulcer bleeding
Other Name: EGF

Active Comparator: Injection Tx Device: Injection Tx
Injection of epinephrine to peptic ulcer bleeding
Other Name: epinephrine injection




Primary Outcome Measures :
  1. Initial hemostasis rate [ Time Frame: Within 10 minutes after first endoscopy session ]
    Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.


Secondary Outcome Measures :
  1. Recurrent bleeding rate [ Time Frame: Within 72 hours ]

    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)

  2. Time required for treatment [ Time Frame: 0 day ]
    The time from when the endoscope is inserted to when the endoscope treatment is completed.

  3. Wound healing effect of peptic ulcer [ Time Frame: After 3 days (72 hours) ]
    Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.

  4. Usability for the delivery system [ Time Frame: 0 day ]
    Evaluation of success for the delivery system



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469167


Sponsors and Collaborators
CGBio Inc.
Investigators
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Principal Investigator: Don Haeng Lee, MD. PhD. Inha University Hospital
Principal Investigator: Su Jin Hong, MD. PhD. Soon Chun Hyang University

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Responsible Party: CGBio Inc.
ClinicalTrials.gov Identifier: NCT03469167     History of Changes
Other Study ID Numbers: CGB-01
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CGBio Inc.:
Bleeding
Additional relevant MeSH terms:
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Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Epinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents