NCT04991688 (BOTOX-TME) is a Phase 2 clinical trial of BOTOX-A in Low Anterior Resection Syndrome (LARS>20), sponsored by University Hospital, Bordeaux.

Who is sponsoring NCT04991688?

NCT04991688 is sponsored by University Hospital, Bordeaux.

What drugs are being tested in NCT04991688?

Interventions in NCT04991688: BOTOX-A.

What condition does NCT04991688 study?

NCT04991688 studies Low Anterior Resection Syndrome (LARS>20), Refractory Medical Treatment After Rectal Resection.

Is NCT04991688 still recruiting?

NCT04991688 is currently terminated. Last updated 27 October 2023.

Last reviewed 2023-10-27 · How we verify

NCT04991688: BOTOX-TME

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Prospective Pilot Study to Assess the Efficacy of BOTOX-A in Patients With Low Anterior Resection Syndrome (LARS>20) and Refractory Medical Treatment After Rectal Resection

Terminated Phase 2 Last updated 27 October 2023

What this trial tests

Phase 2 trial testing BOTOX-A in Low Anterior Resection Syndrome (LARS>20) in 11 participants. Terminated before completion.

Timeline

1 September 2021

Primary endpoint
7 January 2023

3 March 2023

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	1 September 2021
Primary completion	7 January 2023
Estimated completion	3 March 2023
Sites	1 location across France

Drugs / interventions tested

BOTOX-A — full drug profile →

Conditions studied

Low Anterior Resection Syndrome (LARS>20) — all drugs for Low Anterior Resection Syndrome (LARS>20) →
Refractory Medical Treatment After Rectal Resection — all drugs for Refractory Medical Treatment After Rectal Resection →

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, any sex, with Low Anterior Resection Syndrome (LARS>20) or Refractory Medical Treatment After Rectal Resection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

After rectal resection for cancer (with or without stoma), patients may have digestive sequelae. LARS (Low Anterior Resection Syndrome) includes bowel frequency, stool fragmentation, urgency, and faecal incontinence. The goal of this study is to test intra-rectal BOTOX-A on functional outcomes and quality of life of patients with LARS refractory to medical treatment at 3 months after surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other University Hospital, Bordeaux trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04991688 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Bordeaux
Last refreshed: 27 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04991688.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing