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Completed

NCT Number: NCT03469167

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

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.

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Key information

Conditions

Peptic Ulcer Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Hemorrhage

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CEGP003

Device

Application of CEGP003 to peptic ulcer bleeding

Other names: EGF

Injection Tx

Device

Injection of epinephrine to peptic ulcer bleeding

Other names: epinephrine injection

Primary outcomes

  1. Initial hemostasis rate

    Time frame: Within 10 minutes after first endoscopy session

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

Secondary outcomes

  1. 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)

  2. Time required for treatment

    Time frame: 0 day

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

  3. Wound healing effect of peptic ulcer

    Time frame: After 3 days (72 hours)

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

  4. Usability for the delivery system

    Time frame: 0 day

    Evaluation of success for the delivery system

Sponsors and collaborators

Lead sponsor

CGBio Inc.

Industry

Registry information

Official study 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

Acronym: CEGP003

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Mar 19, 2018
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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