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

Peptic Ulcer Bleeding Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469167
• Other study ID #: CGB-01
• Status: Completed
• Phase: N/A
• First received: March 5, 2018
• Last updated: March 16, 2018
• Start date: October 15, 2014
• Est. completion date: January 2, 2017

Study information

• Verified date: March 2018
• Source: CGBio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2, 2017
• Est. primary completion date: November 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Bleeding
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Device:
• CEGP003
Application of CEGP003 to peptic ulcer bleeding
• Injection Tx
Injection of epinephrine to peptic ulcer bleeding

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CGBio Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial hemostasis rate	Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.	Within 10 minutes after first endoscopy session
Secondary	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
Secondary	Time required for treatment	The time from when the endoscope is inserted to when the endoscope treatment is completed.	0 day
Secondary	Wound healing effect of peptic ulcer	Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.	After 3 days (72 hours)
Secondary	Usability for the delivery system	Evaluation of success for the delivery system	0 day