Adrenomedullin for steroid-resistant ulcerative colitis: a randomized, double-blind, placebo-controlled phase-2a clinical trial

What Was Tested

The paper reports a study of Adrenomedullin, published as a randomized controlled trial.

Adrenomedullin (AM) is a bioactive peptide having many pleiotropic effects, including mucosal healing and immunomodulation.

JAPIC clinical trials information; Japic CTI-205255 (200410115290). https://www.clinicaltrials.jp/cti-user/trial/Search.jsp .

Who Took Part

According to the abstract, 28 patients were involved.

The age groups tagged for this paper are teenagers, adults, middle-aged adults and older adults, both men and women.

This was a multi-center, double-blind, placebo-controlled phase-2a trial evaluating 28 patients in Japan with steroid-resistant UC.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

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

Blinding on both sides kept the patients and researchers unaware of who received Adrenomedullin.

A placebo (an inactive look-alike) gave the Adrenomedullin group a baseline to be compared against.

The primary endpoint was the change in Mayo scores at 2 weeks.

Main secondary endpoints included the change in Mayo scores and the rate of clinical remission at 8 weeks, defined as a Mayo score 0.

What Was Measured

The subject headings attached to it are Adrenomedullin, Colitis, Ulcerative, Drug Resistance and Japan.

Author keywords: Japanese, Phase 2a clinical trial and Ulcerative colitis.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Adrenomedullin in 28 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 4 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2021 (Journal of gastroenterology), a journal based in Japan.

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