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.
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:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 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.
- Between 18 and 65 years old
- 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:,
- presence of associated gastrointestinal symptoms such as abdominal bloating and discomfort/nausea, flatulence, gurgling noises from the chest or lower neck.
- Absence of other pharyngeal and esophageal pathologies, determined on the basis of history taking and diagnostic tests.
- 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:
- Participant has a history of surgery in the upper GI tract, that might interfere with the belch reflex (such as anti-reflux surgery)
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- 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.
- 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
- Participation in another interventional Trial with an investigational medicinal product (IMP) or device
- \>65 years old; \< 18 years of age
- Known hypersensitivity to botulinum toxin type A or to human albumin or sodium chloride
- Presence of infection at the proposed injection site(s).
Trial locations and contacts
1 site in 1 country.
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.
- Conditions
- Retrograde Cricopharyngeus Dysfunction
- 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 group | Role | What they receive |
|---|---|---|
| Botulinum toxin injection | Experimental | Not described Receives: Drug: botulinum toxin type A |
| Placebo injection | Placebo comparator | Not 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.
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)
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
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
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.
- First posted10 Apr 2024
- Study start2 Sep 2024
- Primary completion1 Dec 2025
- Study completion27 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrograde Cricopharyngeus DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AZ Delta
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Kathelijne G Delsupehe, MD, Principal investigator, AZ Delta
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Injection in the Upper Esophageal Sphincter for Retrograde-cricopharyngeus Dysfunction: a Prospective, Double Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06356025
- Acronym / sponsor ID
- BOTUS R-CPD / 52082
- Conditions
- Retrograde Cricopharyngeus Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AZ DeltaUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 27 Oct 2026 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin injection | Experimental | Drug: botulinum toxin type A |
| Placebo injection | Placebo comparator | Drug: Sodium Chloride 0.9% Inj |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin type ABotulinum toxin type A 75U dissolved in 3mL physiological serum injection in the upper esophageal sphincter | Drug | Botulinum toxin injection |
| Sodium Chloride 0.9% InjPlacebo: physiological serum 3mL injection in the upper esophageal sphincter | Drug | Placebo injection |
Primary outcome
Response to Botox versus placebo, 12 weeks after treatment.
Time frame: 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.
3 secondary outcomes
Response to botox versus placebo 48 weeks after treatment.
Time frame: 48 weeks
Safety: count of each type of (serious) adverse events in each group
Time frame: 4 weeks
Safety on swallowing: with SSQ
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathelijne G Delsupehe, MD principal investigator
AZ Delta
1 site in 1 country: see every site and its status.
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.