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Botulinum Toxin Injection in the UES for R-CPD
Sponsor: AZ Delta
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
Conditions
Interventions
botulinum toxin type A
Botulinum toxin type A 75U dissolved in 3mL physiological serum injection in the upper esophageal sphincter
Sodium Chloride 0.9% Inj
Placebo: physiological serum 3mL injection in the upper esophageal sphincter
Locations (1)
AZ Delta
Roeselare, Belgium