CClinicalTrials.gg
Sign In
CompletedNCT03469167CEGP003Updated Mar 19, 2018

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

An interventional study of CEGP003 and Injection Tx in Peptic Ulcer Bleeding, sponsored by CGBio Inc.. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-03-19.

Sponsored by CGBio Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peptic Ulcer Bleeding

Keywords

  • Bleeding
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    CEGP003

    Device: CEGP003

  • Active comparator
    Injection Tx

    Device: Injection Tx

Interventions

  • DeviceCEGP003

    Application of CEGP003 to peptic ulcer bleeding

    Also known as: EGF

  • DeviceInjection Tx

    Injection of epinephrine to peptic ulcer bleeding

    Also known as: epinephrine injection

05

What researchers measure

Primary outcomes

  1. Initial hemostasis rate

    Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.

    Time frame: Within 10 minutes after first endoscopy session

Secondary outcomes

  1. 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)

    Time frame: Within 72 hours

  2. Time required for treatment

    The time from when the endoscope is inserted to when the endoscope treatment is completed.

    Time frame: 0 day

  3. Wound healing effect of peptic ulcer

    Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.

    Time frame: After 3 days (72 hours)

  4. Usability for the delivery system

    Evaluation of success for the delivery system

    Time frame: 0 day

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03469167
Lead sponsor
CGBio Inc.
Responsible party
Sponsor
First posted
Mar 19, 2018
Start date
Oct 15, 2014
Primary completion
Nov 10, 2015
Completion
Jan 2, 2017
Last update
Mar 19, 2018

Study contacts

Don Haeng Lee, MD. PhD.
principal investigator · Inha University Hospital
Su Jin Hong, MD. PhD.
principal investigator · Soon Chun Hyang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Peptic Ulcer→

Other studies from this sponsor

CGBio Inc.

Start the discussion