STEPS — structured trial abstract

§1Structured abstract

§1.1Objective

To evaluate Teduglutide in inflammatory bowel disease and mucosal barrier disorders, against the comparator specified in §2, with the primary endpoint stated below.

§1.2Design

Design

Randomised, double-blind, placebo-controlled, parallel-group

Masking

Double-blind (participant, investigator and sponsor)

Phase

Phase 3

Randomised participants

86

Duration of the primary analysis period

24 weeks

Sponsor class

Manufacturer-sponsored

Registry identifier

not reproduced — see the note in §1.5

§1.3Primary endpoint

Proportion achieving a 20 % to 100 % reduction in weekly parenteral support volume at weeks 20 and 24 in short-bowel syndrome with intestinal failure

§1.4Principal result

Response in 63 % versus 30 % with placebo.

The pivotal trial for the approved indication. The Institute records it in full because it is the only randomised evidence for any glucagon-like peptide-2 analogue, and because the uses under which analogues of this compound are supplied for research bear no relation to it.

§1.5Provenance of this abstract

Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.