Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding (CEGP003)
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|ClinicalTrials.gov Identifier: NCT03469167|
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peptic Ulcer Bleeding||Device: CEGP003 Device: Injection Tx||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||October 15, 2014|
|Actual Primary Completion Date :||November 10, 2015|
|Actual Study Completion Date :||January 2, 2017|
Application of CEGP003 to peptic ulcer bleeding
Other Name: EGF
|Active Comparator: Injection Tx||
Device: Injection Tx
Injection of epinephrine to peptic ulcer bleeding
Other Name: epinephrine injection
- Initial hemostasis rate [ Time Frame: Within 10 minutes after first endoscopy session ]Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.
- Recurrent bleeding rate [ Time Frame: 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 [ Time Frame: 0 day ]The time from when the endoscope is inserted to when the endoscope treatment is completed.
- Wound healing effect of peptic ulcer [ Time Frame: After 3 days (72 hours) ]Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.
- Usability for the delivery system [ Time Frame: 0 day ]Evaluation of success for the delivery system
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469167
|Principal Investigator:||Don Haeng Lee, MD. PhD.||Inha University Hospital|
|Principal Investigator:||Su Jin Hong, MD. PhD.||Soon Chun Hyang University|