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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Peptic Ulcer Bleeding

Intervention / Treatment
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* Device: CEGP003
* Device: Injection Tx


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEGP003<br> | Device: CEGP003<br>* Application of CEGP003 to peptic ulcer bleeding<br>* Other names: EGF;|
| Active Comparator: Injection Tx<br> | Device: Injection Tx<br>* Injection of epinephrine to peptic ulcer bleeding<br>* Other names: epinephrine injection;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleeding