The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer

What Was Tested

In this not phased trial, researchers set out to test Carnosine.

Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract.

ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome.

Several procedure-related complications may occur after ESD.

It had two arms (groups): Rebamipide group (active comparator) and Polaprezinc group (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 153 actual participants took part.

It was open to people of any sex aged from 19 years up to 79 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age, between 19 and 79. Patients with gastric adenoma or early gastric cancer. Patients with ECOG-PS 0 or 1. Patients with adequate renal function. Patients with adequate hepatic function.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: patients who has taken the medications for ulcer including ppis, h2 blockers, and mucosal protective agents within 3 months prior to the esd; patients who has taken steroid or nsaidswithin 3 months prior to the esd; patients who has undergone gastrostomy.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Carnosine and who got the comparison, which limits bias.

The Carnosine group and the comparison group ran side by side rather than switching.

Being open-label, the Carnosine study did not mask who received what.

It started in 2015-01-14 with completion listed for 2016-04-14.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Ulcering healing rate (time frame: 4 weeks after the ESD).

It also tracked 1 secondary outcome, for example Scarring change rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 153 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, all human trials.