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

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

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.

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer Bleeding
• Intervention / Treatment: Device: CEGP003; Device: Injection Tx

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CEGP003	Device: CEGP003; Application of CEGP003 to peptic ulcer bleeding; Other Names: EGF
Active Comparator: Injection Tx	Device: Injection Tx; Injection of epinephrine to peptic ulcer bleeding; Other Names: epinephrine injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial hemostasis rate	Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.	Within 10 minutes after first endoscopy session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Within 72 hours
Time required for treatment	The time from when the endoscope is inserted to when the endoscope treatment is completed.	0 day
Wound healing effect of peptic ulcer	Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.	After 3 days (72 hours)
Usability for the delivery system	Evaluation of success for the delivery system	0 day

Collaborators and Investigators

• Sponsor: CGBio Inc.
• Investigators: Principal Investigator: Don Haeng Lee, MD. PhD., Inha University Hospital; Principal Investigator: Su Jin Hong, MD. PhD., Soon Chun Hyang University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2014
• Primary Completion (Actual): November 10, 2015
• Study Completion (Actual): January 2, 2017

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Ulcer; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Hemostatics; Coagulants; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; CEGP-003
• Other Study ID Numbers: CGB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No