Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding
CEGP003
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
1 other identifier
interventional
76
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2017
CompletedFirst Submitted
Initial submission to the registry
March 5, 2018
CompletedFirst Posted
Study publicly available on registry
March 19, 2018
CompletedMarch 19, 2018
March 1, 2018
1.1 years
March 5, 2018
March 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Initial hemostasis rate
Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.
Within 10 minutes after first endoscopy session
Secondary Outcomes (4)
Recurrent bleeding rate
Within 72 hours
Time required for treatment
0 day
Wound healing effect of peptic ulcer
After 3 days (72 hours)
Usability for the delivery system
0 day
Study Arms (2)
CEGP003
EXPERIMENTALInjection Tx
ACTIVE COMPARATORInterventions
Injection of epinephrine to peptic ulcer bleeding
Eligibility Criteria
You may qualify if:
- Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CGBio Inc.lead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Don Haeng Lee, MD. PhD.
Inha University Hospital
- PRINCIPAL INVESTIGATOR
Su Jin Hong, MD. PhD.
Soon Chun Hyang University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2018
First Posted
March 19, 2018
Study Start
October 15, 2014
Primary Completion
November 10, 2015
Study Completion
January 2, 2017
Last Updated
March 19, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share