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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-15

Study Completion Date

2017-01-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

NCT06543316

Roux-en-y Anastomosis Site Marginal Ulcer Marginal Ulcer (Peptic) or Erosion +9 more

RECRUITING NA

Surveillance of Bleeding Peptic Ulcer Using Wireless Capsule Endoscopy

NCT00164827

Bleeding Peptic Ulcer

UNKNOWN

To Compare a Hemostatic Powder TC-325 and Standard Treatment in the Control of Acute Upper Gastrointestinal Bleeding From Nonvariceal Causes

NCT02534571

Acute Upper Gastrointestinal Bleeding

COMPLETED PHASE3

Argon Plasma Coagulation for Bleeding Peptic Ulcers

NCT02241044

Bleeding Ulcers

COMPLETED PHASE4

Combined Endoscopic & Radiologic Intervention For Management Of Acute Perforated Peptic Ulcer

NCT05051683

Abdomen, Acute

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peptic Ulcer Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CEGP003

Group Type EXPERIMENTAL

CEGP003

Intervention Type DEVICE

Application of CEGP003 to peptic ulcer bleeding

Injection Tx

Group Type ACTIVE_COMPARATOR

Injection Tx

Intervention Type DEVICE

Injection of epinephrine to peptic ulcer bleeding

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CEGP003

Application of CEGP003 to peptic ulcer bleeding

Intervention Type DEVICE

Injection Tx

Injection of epinephrine to peptic ulcer bleeding

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EGF epinephrine injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No