Dysphagia, EsophagealPhase 4NCT05629325
Buspirone for Weak or Absent Esophageal Peristalsis
A Phase 4 study testing Buspirone Hydrochloride 10 MG in people with Dysphagia, Esophageal, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This is a randomized, double-blind, placebo-controlled, cross-over clinical trial of buspirone in patients with complaints of dysphagia due to poor esophageal motility. The goal of this clinical trial is to study the effect of buspirone on esophageal motility by performing high resolution impedance manometry (HRiM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Esophageal
- What is being tested?
- Buspirone Hydrochloride 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jul 2021to 30 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients can participate in this study if:
- A minimum of 18 years old;
- Ineffective Esophageal Motility (IEM) or absent contractility, as determined on HRM in the last three months before inclusion in the study, using the Chicago classification v4.0 (1).
- IEM is defined as >70% ineffective or ≥50% failed swallows with a normal integrated relaxation pressure (IRP4). IEM includes a weak contraction (DCI ≥ 100 mmHg·s·cm and <450 mmHg·s·cm), failed peristalsis (DCI < 100 mmHg·s·cm), or fragmented peristalsis (a large break (>5 cm length) in the 20-mmHg isobaric contour with DCI > 450 mmHg·s·cm).
- Absent contractility is defined as 100% failed swallows (DCI < 100 mmHg·s·cm), with a normal IRP4.
- Have completed a gastro-duodenoscopy, within 12 months, showing no anatomical abnormality of the stomach or esophagus, which can explain the patients' symptoms.
Show all 9Show fewer
- History of dysphagia for at least 2 months, at least twice per week in the last month.
- Sexually active women of childbearing potential participating in the study must be using an appropriate form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. If the female patient has not been on oral, injectable, implantable or intrauterine contraception, a urinary pregnancy test will be performed prior to administration of Buspirone/Placebo.
- Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
Who cannot join
- Patients cannot participate in this study if:
- Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed off PPI treatment in the 12 months prior to screening, or ≥ grade B when endoscopy is performed during PPI treatment.
- Systemic diseases, known to affect esophageal motility (i.e. systemic sclerosis)
- Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
- Hiatal hernia ≥3 cm
- QT c>450 ms.
Show all 15Show fewer
- Use of medication that effect cholinergic function such as anticholinergics, tricyclic antidepressants.
- Concomitant promotility agents such as prucalopride or domperidone.
- Concomitant use of more than one benzodiazepine.
- Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
- Major psychiatric disorder.
- Pregnancy or breastfeeding.
- History of poor compliance.
- History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
Jan Tack, M.D., Ph.D., +3216345514, jan.tack@kuleuven.be
Jan Tack, M.D., Ph.D.
About this study
Official title: The Effect of Oral Buspirone Hydrochloride on Esophageal Motility, Bolus Transit and Symptoms of Dysphagia, in Patients With Poor Esophageal Motility: A Randomized, Double-blind, Placebo Controlled, Cross-over Trial With HRiM
This is a randomized, double-blind, placebo-controlled, cross-over clinical trial of buspirone in patients with complaints of dysphagia due to poor esophageal motility. The goal of this clinical trial is to study the effect of buspirone on esophageal motility by performing high resolution impedance manometry (HRiM).
Read the detailed description
Esophageal motility disorders can be characterized by poor esophageal motility with impaired clearance of the esophagus. Examples are Ineffective Esophageal Motility (IEM, >70% of the swallows are ineffective or ≥50% are failed) and Absent Contractility (100% failed peristalsis). Both might be the underlying cause for dysphagia.
Several studies have shown that poor esophageal motility can be manipulated by pharmacological means. Buspirone, a 5-HT1A agonist, is able to significantly increase distal esophageal wave amplitude and duration in healthy volunteers, suggesting it may be effective in IEM. At the moment, findings in patients with IEM are not consistent and depend on the dose and treatment duration.
This cross-over trial will examine the use of buspirone in patients with dysphagia, with the intent of using a higher dose. We will use impedance/manometry and pressure flow analysis to liquid, viscous and solid boluses to evaluate the symptomatic and manometric effect of buspirone.
- Conditions
- Dysphagia, Esophageal
- Being tested
- Buspirone Hydrochloride 10 MG, Placebo
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buspirone Hydrochloride 10 MGDrug
Also called Buspiron
4 weeks of treatment with buspirone
PlaceboDrug
4 weeks of treatment with placebo
| Study group | Role | What they receive |
|---|---|---|
| Buspirone => Washout => Placebo | Experimental | Patients will take Buspirone hydrochloride 10mg oral once a day (in the evening) for 3 days, twice a day (morning and evening) for 4 days, three times a day for 2 weeks and 20mg oral three times a day for one week. Esophageal motility will be assessed with high resolution impedance manometry (HRiM) after 4 weeks of treatment. Patients will also report their perceived symptoms of dysphagia during the HRiM. A washout period of two weeks will take place. Afterwards, the second treatment period starts. Patients will take Placebo oral once a day (in the evening) for 3 days, twice a day (morning and evening) for 4 days, three times a day for 2 weeks and 20mg oral three times a day for one week. Esophageal motility will also be assessed with high resolution impedance manometry (HRiM) after 4 weeks of treatment. Patients will again report their perceived symptoms of dysphagia during the HRiM. Receives: Drug: Buspirone Hydrochloride 10 MG; Drug: Placebo |
| Placebo => Washout => Buspirone | Experimental | Patients will take Placebo oral once a day (in the evening) for 3 days, twice a day (morning and evening) for 4 days, three times a day for 2 weeks and 20mg oral three times a day for one week. Esophageal motility will be assessed with high resolution impedance manometry (HRiM) after 4 weeks of treatment. Patients will also report their perceived symptoms of dysphagia during the HRiM. A washout period of two weeks will take place. Afterwards, the second treatment period starts. Patients will take Buspirone hydrochloride oral once a day (in the evening) for 3 days, twice a day (morning and evening) for 4 days, three times a day for 2 weeks and 20mg oral three times a day for one week. Esophageal motility will also be assessed with high resolution impedance manometry (HRiM) after 4 weeks of treatment. Patients will again report their perceived symptoms of dysphagia during the HRiM. Receives: Drug: Buspirone Hydrochloride 10 MG; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRiM Manometric Features: DCI 5ml supine
Changes in distal contractile integral (DCI, in mmHg*s*cm) between buspirone and placebo. DCI is established on HRiM. As primary endpoint, we will focus on the values for DCI for the liquid bolus, 5 ml in supine position.
Measured: During manometric assessment after 4 weeks of treatment
Secondary outcomes (20)
Bolus passage score
Patients will evaluate the perception of each swallow during the manometric assessment via the following Likert score: 1-Normal, 2-Slow passage of bolus, 3-Stepwise passage, 4-Partial Blockage, 5-Complete Blockage.
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: PCI
Pharyngeal Esophageal Contractile Integral (PCI es., mm.Hg.s.cm)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DCI
Distal Esophageal Contractile Integral (DCI, mmHg.s.cm)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: Largest Break Size
Largest Break Size (cm)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DL
Distal Latency (DL, s)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: IRP4s
Integrated Relaxation Pressure EGJ 4sec (IRP4s, mmHg)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: PFI
Pressure Flow Index (PFI, -)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: IR
Impedance Ratio (IR, -)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DPA
Distension Pressure Accommodation Phase (DPA, mmHg)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DPE
Distension Pressure Emptying Phase (DPE, mmHg)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: RP
Distal Ramp Pressure (RP, mmHg/s)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: CSI
Contractile Segment Impedance (CSI, Ohm)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: BPT
Bolus Presence Time (BPT, s)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: BFT
Bolus Flow Time (BFT, s)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: EGJ Rest.P
EGJ Resting Pressure (EGJ Rest.P, mmHg)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: EGJCI
EGJ Contractile Integral (EGJCI, mmHg.cm)
Measured: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: LES-CD
Lower Esophageal Sphincter - Crural Diaphragm (LES-CD, mm)
Measured: During manometric assessment after 4 weeks of treatment
Mayo Dysphagia Questionnaire
Symptom questionnaire
Measured: At baseline and after 4 weeks of treatment
Overall Treatment Evaluation (OTE)
Symptoms questionnaire
Measured: At baseline and after 4 weeks of treatment
Overall Symptom Severity (OSS)
Symptom questionnaire
Measured: At baseline and after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start6 Jul 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia, EsophagealStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Patients with IEM or absent contractility and symptoms of dysphagia will participate in this study. They will be randomized on a 1:1 basis: Patients will be randomized to take buspirone for 4 weeks or placebo for 4 weeks. After a 2-week washout period the randomized groups will cross over into the alternate treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629325
- Sponsor's protocol ID
- S62876
- Status last verified
- Jul 2024
- First submitted
- 8 Nov 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Buspirone Hydrochloride on Esophageal Motility, Bolus Transit and Symptoms of Dysphagia, in Patients With Poor Esophageal Motility: A Randomized, Double-blind, Placebo Controlled, Cross-over Trial With HRiM
- ClinicalTrials.gov ID
- NCT05629325
- Acronym / sponsor ID
- S62876
- Conditions
- Dysphagia, Esophageal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 29 Nov 2022 (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.
This is a randomized, double-blind, placebo-controlled, cross-over clinical trial of buspirone in patients with complaints of dysphagia due to poor esophageal motility. The goal of this clinical trial is to study the effect of buspirone on esophageal motility by performing high resolution impedance manometry (HRiM).
Detailed description
Esophageal motility disorders can be characterized by poor esophageal motility with impaired clearance of the esophagus. Examples are Ineffective Esophageal Motility (IEM, >70% of the swallows are ineffective or ≥50% are failed) and Absent Contractility (100% failed peristalsis). Both might be the underlying cause for dysphagia.
Several studies have shown that poor esophageal motility can be manipulated by pharmacological means. Buspirone, a 5-HT1A agonist, is able to significantly increase distal esophageal wave amplitude and duration in healthy volunteers, suggesting it may be effective in IEM. At the moment, findings in patients with IEM are not consistent and depend on the dose and treatment duration.
This cross-over trial will examine the use of buspirone in patients with dysphagia, with the intent of using a higher dose. We will use impedance/manometry and pressure flow analysis to liquid, viscous and solid boluses to evaluate the symptomatic and manometric effect of buspirone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with IEM or absent contractility and symptoms of dysphagia will participate in this study. They will be randomized on a 1:1 basis: Patients will be randomized to take buspirone for 4 weeks or placebo for 4 weeks. After a 2-week washout period the randomized groups will cross over into the alternate treatment.
| Arm | Type | Receives |
|---|---|---|
| Buspirone => Washout => Placebo | Experimental | Drug: Buspirone Hydrochloride 10 MG, Drug: PlaceboPatients will take Buspirone hydrochloride 10mg oral once a day (in the evening) for 3 days, twice a day (morning and evening) for 4 days, three times a day for 2 weeks and 20mg oral three times a day for one week. Esophageal motility will be assessed with high resolution impedance manometry (HRiM) after 4 weeks of treatment. Patients will also report their perceived symptoms of dysphagia during the HRiM. A washout period of two weeks will take place. Afterwards, the second treatment period starts. Patients will take Placebo oral once a day (in the evening) for 3 days, twice a day (morning and evening) for 4 days, three times a day for 2 weeks and 20mg oral three times a day for one week. Esophageal motility will also be assessed with high resolution impedance manometry (HRiM) after 4 weeks of treatment. Patients will again report their perceived symptoms of dysphagia during the HRiM. |
| Placebo => Washout => Buspirone | Experimental | Drug: Buspirone Hydrochloride 10 MG, Drug: PlaceboPatients will take Placebo oral once a day (in the evening) for 3 days, twice a day (morning and evening) for 4 days, three times a day for 2 weeks and 20mg oral three times a day for one week. Esophageal motility will be assessed with high resolution impedance manometry (HRiM) after 4 weeks of treatment. Patients will also report their perceived symptoms of dysphagia during the HRiM. A washout period of two weeks will take place. Afterwards, the second treatment period starts. Patients will take Buspirone hydrochloride oral once a day (in the evening) for 3 days, twice a day (morning and evening) for 4 days, three times a day for 2 weeks and 20mg oral three times a day for one week. Esophageal motility will also be assessed with high resolution impedance manometry (HRiM) after 4 weeks of treatment. Patients will again report their perceived symptoms of dysphagia during the HRiM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A minimum of 18 years old;
- Ineffective Esophageal Motility (IEM) or absent contractility, as determined on HRM in the last three months before inclusion in the study, using the Chicago classification v4.0 (1).
- IEM is defined as >70% ineffective or ≥50% failed swallows with a normal integrated relaxation pressure (IRP4). IEM includes a weak contraction (DCI ≥ 100 mmHg·s·cm and <450 mmHg·s·cm), failed peristalsis (DCI < 100 mmHg·s·cm), or fragmented peristalsis (a large break (>5 cm length) in the 20-mmHg isobaric contour with DCI > 450 mmHg·s·cm).
- Absent contractility is defined as 100% failed swallows (DCI < 100 mmHg·s·cm), with a normal IRP4.
- Have completed a gastro-duodenoscopy, within 12 months, showing no anatomical abnormality of the stomach or esophagus, which can explain the patients' symptoms.
Key exclusion criteria (15 listed)
- Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed off PPI treatment in the 12 months prior to screening, or ≥ grade B when endoscopy is performed during PPI treatment.
- Systemic diseases, known to affect esophageal motility (i.e. systemic sclerosis)
- Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
- Hiatal hernia ≥3 cm
- QT c>450 ms.
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 |
|---|---|---|
| Buspirone Hydrochloride 10 MGAlso: Buspiron4 weeks of treatment with buspirone | Drug | Buspirone => Washout => Placebo, Placebo => Washout => Buspirone |
| Placebo4 weeks of treatment with placebo | Drug | Buspirone => Washout => Placebo, Placebo => Washout => Buspirone |
Primary outcome
HRiM Manometric Features: DCI 5ml supine
Time frame: During manometric assessment after 4 weeks of treatment
Changes in distal contractile integral (DCI, in mmHg*s*cm) between buspirone and placebo. DCI is established on HRiM. As primary endpoint, we will focus on the values for DCI for the liquid bolus, 5 ml in supine position.
20 secondary outcomes
Bolus passage score
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: PCI
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DCI
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: Largest Break Size
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DL
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: IRP4s
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: PFI
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: IR
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DPA
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: DPE
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: RP
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: CSI
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: BPT
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: BFT
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: EGJ Rest.P
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: EGJCI
Time frame: During manometric assessment after 4 weeks of treatment
HRiM Manometric Features: LES-CD
Time frame: During manometric assessment after 4 weeks of treatment
Mayo Dysphagia Questionnaire
Time frame: At baseline and after 4 weeks of treatment
Overall Treatment Evaluation (OTE)
Time frame: At baseline and after 4 weeks of treatment
Overall Symptom Severity (OSS)
Time frame: At baseline and after 4 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Jan Tack principal investigator
UZ Leuven
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 Buspirone Hydrochloride 10 MG in people with Dysphagia, Esophageal, run by Universitaire Ziekenhuizen KU Leuven 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?
The sponsor lists 9 inclusion and 15 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Tack (+3216345514, jan.tack@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRiM Manometric Features: DCI 5ml supine (time frame: During manometric assessment after 4 weeks of treatment). 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 3 Jul 2024.