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ACTIVE NOT RECRUITING
NCT06356025
PHASE4

Botulinum Toxin Injection in the UES for R-CPD

Sponsor: AZ Delta

View on ClinicalTrials.gov

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.

Official title: Botulinum Toxin Injection in the Upper Esophageal Sphincter for Retrograde-cricopharyngeus Dysfunction: a Prospective, Double Blind, Placebo-controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-09-02

Completion Date

2027-03

Last Updated

2025-12-08

Healthy Volunteers

No

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

Locations (1)

AZ Delta

Roeselare, Belgium