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

Not Applicable

Completed

• Conditions: Peptic Ulcer Bleeding

• Registration Number: NCT03469167
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-10-15
• Primary Completion: 2015-11-10
• Study Completion: 2017-01-02
• Status Verified: 2018-03
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-16
• Last Update Submitted: 2018-03-16
• Study First Posted: 2018-03-19
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Initial hemostasis rate	Within 10 minutes after first endoscopy session	Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.

Secondary Outcome Measures

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