NCT01308177

Efficacy of an Ecabet Sodium and Proton Pump Inhibitor (PPI) Combination Therapy in the Treatment of Iatrogenic Ulcer After Endoscopic Submucosal Dissection: A Prospective Randomized Controlled Trial

Status unknown Phase 4 Last updated 2 March 2011

What this trial tests

Phase 4 trial testing Ecabet in Delayed Bleeding, in 90 participants. Status unknown.

Timeline

1 March 2011

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	90
Start date	1 March 2011
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	1 location across South Korea

Drugs / interventions tested

• Ecabet — full drug profile →

Conditions studied

• Delayed Bleeding, — all drugs for Delayed Bleeding, →
• Healing Ulcer — all drugs for Healing Ulcer →
• Quality of Ulcer — all drugs for Quality of Ulcer →

Sponsor

Samsung Medical Center

Who can join

Adults 18 to 80, any sex, with Delayed Bleeding, or Healing Ulcer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• to determine the difference in delayed bleeding with PPI or PPI+ES
  Time frame: the time of bleeding occured or post 4 weeks after ESD

Sponsor's own description

* Endoscopic submucosal dissection (ESD) is widely indicated to treat gastric adenomas and early gastric cancer (EGC).ESD is able to obtain en bloc resection of larger specimens. However, ESD has more frequent complications (delayed bleeding, ulcer healing, ulcer pain, and etc) due to a more complex procedure. To prevent delayed bleeding, to induce rapid ulcer healing, and to control the ulcer pain acid-suppressing agents (PPI, H2RA) are generally administered. although PPIs are widely indicated as first-line drugs for peptic ulcers, PPI drugs are not fully superior to H2RAs or other combination drugs for treatment of iatrogenic ulcer healing and delayed bleeding.
* Ecabet sodium (ES)is a widely used mucoprotective agent for the treatment of gastric ulcers. Recently, one study showed the additional benefits of using ES in combination with the PPI after ESD. however, this study did not show the difference of delayed bleeding and the benefit of ulcer pain control. thus, our study prospectively evaluated the difference of delayed bleeding and the benefit of ulcer pain control after ESD.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.