Botulinum Toxin Injection in the UES for R-CPD

Phase 4

Recruiting

• Conditions: Retrograde Cricopharyngeus Dysfunction
• Interventions: Drug: Sodium Chloride 0.9% Inj; Drug: botulinum toxin type A

• Registration Number: NCT06356025
• Lead Sponsor: AZ Delta

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-10
• Study Start: 2024-09-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo injection	Sodium Chloride 0.9% Inj	-
Botulinum toxin injection	botulinum toxin type A	-

Primary Outcome Measures

Name	Time	Method
Response to Botox versus placebo, 12 weeks after treatment.	week 12	This questionnaire is a treatment effect measure specific for inability to belch, where the change in symptoms from baseline is assessed, on a scale from 0% to 100%. 100% means complete resolution of symptoms, 0% means no improvement.

Secondary Outcome Measures

Name	Time	Method
Response to botox versus placebo 48 weeks after treatment.	48 weeks	We will use the questionnaire of 'Difficulties with belching', and response is defined as at least a 50% improvement on question 6A 'To what extent have the symptoms of \'difficulty burping air\' been reduced after treatment?\'.
Safety: count of each type of (serious) adverse events in each group	4 weeks	Safety: assessed by the number and type of (serious) adverse events that occurred in each group by week 48
Safety on swallowing: with SSQ	4 weeks	assessed by the Sydney Swallow Questionnaire 1 week and 4 weeks after the procedure.

Trial Locations

Locations (1)

AZ Delta; 🇧🇪 Roeselare, Belgium