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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03469167

Acronym

CEGP003

Enrollment

Registered

2018-03-19

Start date

2014-10-15

Completion date

2017-01-02

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer Bleeding

Keywords

Bleeding

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.

Interventions

DEVICECEGP003

Application of CEGP003 to peptic ulcer bleeding

DEVICEInjection Tx

Injection of epinephrine to peptic ulcer bleeding

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026