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Clinical Trials in the EU / 2025-524342-96-00
Authorised, not yet recruiting Phase II

Colonic Intramural Injections of Botulin toxin versus placebo to treat fragmented defecation and urgency after restorative total mesorectal excision (TME) for rectal cancer

2025-524342-96-00 · tracked via the Priya Life Science EU tracker
Sponsor
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Digestive System Diseases
Decision date
02/04/2026
Enrollment target
20
Sites
Belgium

Condition studied

Rectal Cancer

Investigational medicinal product(s)

BOTOX 100 Allergan Units Powder for solution for injection0.9% sodium chloride solution for injection (NaCl 0.9%).

Every trial of Botulinum toxin type A across our registers →

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Primary endpoint: Difference in LARS score between BoNTA and placebo groups at 3 months.

Endpoint detail

- Secondary endpoints: Clinical assessments at 1, 3, and 6 months; patient-reported outcomes (LARS, Wexner, EORTC QLQ-C30 and QLQ-CR29); episodes of urgency/fragmented defecation; colonic manometry parameters; adverse events.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524342-96-00 on CTIS ↗ ← All trials in the EU