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Botulinum Toxin Injection in the UES for R-CPD

NCT06356025 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-08

No results posted yet for this study

Summary

The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind, placebo controlled study. Investigators want to assess the effect on symptoms short term (1-20 weeks after BT injection), and long term (48 weeks after BT injection).

This is a prospective double-blind randomized placebo-controlled study. Questionnaires assessing symptoms will be filled out on several occasions. At 20 weeks, a reassessment of symptoms will be done, without unblinding patients or investigator. Failures (to BT or placebo, defined as no clinical improvement or improvement less than 50%) will get the chance to receive a second procedure with active treatment (BT) in open label.

Conditions

  • Retrograde Cricopharyngeus Dysfunction

Interventions

DRUG

botulinum toxin type A

Botulinum toxin type A 75U dissolved in 3mL physiological serum injection in the upper esophageal sphincter

DRUG

Sodium Chloride 0.9% Inj

Placebo: physiological serum 3mL injection in the upper esophageal sphincter

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • AZ Delta

    lead OTHER

Principal Investigators

  • Kathelijne G Delsupehe, MD · AZ Delta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-02
Primary Completion
2025-12-31
Completion
2027-03-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06356025 on ClinicalTrials.gov