Status:
COMPLETED
Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding
Lead Sponsor:
CGBio Inc.
Conditions:
Peptic Ulcer Bleeding
Eligibility:
All Genders
20+ years
Phase:
NA
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 thera...
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 wou...
Eligibility Criteria
Inclusion
- Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)
Exclusion
- 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
Key Trial Info
Start Date :
October 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2017
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03469167
Start Date
October 15 2014
End Date
January 2 2017
Last Update
March 19 2018
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