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

CGBio

Status

Completed

Conditions

Peptic Ulcer Bleeding

Treatments

Device: CEGP003

Device: Injection Tx

Study type

Interventional

Funder types

Industry

Identifiers

NCT03469167

CGB-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 patients

Sex

All

Ages

20+ years old

Volunteers

No 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