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Retrograde Cricopharyngeus DysfunctionPhase 4BOTUS R-CPDNCT06356025

Botulinum Toxin Injection in the UES for R-CPD

A Phase 4 study testing botulinum toxin type A and Sodium Chloride 0.9% Inj in people with Retrograde Cricopharyngeus Dysfunction, run by AZ Delta at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Retrograde Cricopharyngeus Dysfunction
What is being tested?
botulinum toxin type A and Sodium Chloride 0.9% Inj
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteBelgium
Study dates
2 Sep 2024to 27 Oct 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Participants eligible for inclusion in this Trial must meet all of the following criteria:

  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
  3. Between 18 and 65 years old
  4. Inability to belch, which is bothersome enough to consider treatment*, present for at least 6 months prior to inclusion, and in fulfillment of both categories a and b below:,
  5. presence of associated gastrointestinal symptoms such as abdominal bloating and discomfort/nausea, flatulence, gurgling noises from the chest or lower neck.
  6. Absence of other pharyngeal and esophageal pathologies, determined on the basis of history taking and diagnostic tests.
  7. Typical findings on high resolution impedance manometry with belch provocation test (10). These typical findings include: No relaxation upon gastroesophageal gas reflux, no air clearance via the UES but instead an increased air presence time include air entrapment and oscillations.
  • Bothersome = severe enough to impact on usual activities, according to the Rome IV diagnostic criteria (11, 12).

Participants eligible for this Trial must not meet any of the following criteria:

  1. Participant has a history of surgery in the upper GI tract, that might interfere with the belch reflex (such as anti-reflux surgery)
  2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
  3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial, to be decided at the discretion of the investigator.
  4. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential (WOCBP) and not using an adequate, highly effective contraceptive
  5. Participation in another interventional Trial with an investigational medicinal product (IMP) or device
  6. \>65 years old; \< 18 years of age
  7. Known hypersensitivity to botulinum toxin type A or to human albumin or sodium chloride
  8. Presence of infection at the proposed injection site(s).

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • AZ Delta

    Roeselare

Other trials in Belgium

About this study

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

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.

Being tested
botulinum toxin type A, Sodium Chloride 0.9% Inj

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • botulinum toxin type ADrug

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

  • Sodium Chloride 0.9% InjDrug

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

Study groups in NCT06356025
Study groupRoleWhat they receive
Botulinum toxin injectionExperimentalNot described
Receives: Drug: botulinum toxin type A
Placebo injectionPlacebo comparatorNot described
Receives: Drug: Sodium Chloride 0.9% Inj

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response to Botox versus placebo, 12 weeks after treatment.

    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.

    Measured: week 12

Secondary outcomes (3)
  1. Response to botox versus placebo 48 weeks after treatment.

    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?\'.

    Measured: 48 weeks

  2. Safety: count of each type of (serious) adverse events in each group

    Safety: assessed by the number and type of (serious) adverse events that occurred in each group by week 48

    Measured: 4 weeks

  3. Safety on swallowing: with SSQ

    assessed by the Sydney Swallow Questionnaire 1 week and 4 weeks after the procedure.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start2 Sep 2024
  3. Primary completion1 Dec 2025
  4. Study completion27 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06356025
Sponsor's protocol ID
52082
Other IDs
2024-512546-42
Acronym
BOTUS R-CPD
Status last verified
Dec 2025
First submitted
20 Mar 2024
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing botulinum toxin type A and Sodium Chloride 0.9% Inj in people with Retrograde Cricopharyngeus Dysfunction, run by AZ Delta at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to Botox versus placebo, 12 weeks after treatment. (time frame: week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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