Double-blind, randomised, placebo-controlled, phase IIa trial on the efficacy and tolerability of an 8-week treatment with two different doses of budesonide orodispersible tablets vs. placebo for prevention of oesophageal strictures in adult patients after endoscopic submucosal dissection

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507897-42-00

Acronym

BUL-5/ESD

Enrollment

Registered

2023-11-22

Start date

2020-05-12

Completion date

Unknown

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of oesophageal strictures in adult patients after endoscopic submucosal dissection

Brief summary

Percentage of patients free of strictures at visit week 8

Detailed description

Number of endoscopic dilations per patient during the DB treatment phase, Percentage of patients free of strictures until the FU visit

Interventions

DRUGBUL02

DRUGPlacebo orodispersible tablets

DRUGBUL03

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of patients free of strictures at visit week 8	—

Secondary

Measure	Time frame
Number of endoscopic dilations per patient during the DB treatment phase, Percentage of patients free of strictures until the FU visit	—

Countries

France, Germany, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026