Functional DysphagiaNCT02674412
Buspirone for Functional Dysphagia
A study testing Buspirone in people with Functional Dysphagia and Ineffective Esophageal Motility, run by The Cleveland Clinic.
Trial summary
This study evaluates the utility of buspirone in patients who have a diagnosis of functional dysphagia. All participants will be randomized to receive either a placebo pill or buspirone. Subsequently, we will evaluate whether their swallowing is improved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dysphagia, Ineffective Esophageal Motility
- What is being tested?
- Buspirone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to 12 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of IEM per Chicago Classification, v3.0 criteria - as noted above
- Esophagogastroduodenoscopy (EGD) negative for mechanical obstruction
- Esophageal biopsies negative for eosinophilic esophagitis
Who cannot join
- Pregnant women
- Prisoners
- Currently on other serotonin modulating medications
About this study
Official title: Placebo-controlled, Randomized, Double-blind, Cross-over Style Trial of Buspirone in Functional Dysphagia
This study evaluates the utility of buspirone in patients who have a diagnosis of functional dysphagia. All participants will be randomized to receive either a placebo pill or buspirone. Subsequently, we will evaluate whether their swallowing is improved. Participants who were randomized to receive placebo will then receive buspirone and those who were receiving buspirone will receive placebo. We will again evaluate whether their swallowing improved.
Read the detailed description
Buspirone helps to modulate molecules which can affect the activity of the muscles in the esophagus. Studies in the past have shown that in healthy people, buspirone can improve the vigor with which the esophagus squeezes to propel food into the stomach. In patients with functional dysphagia, the esophagus muscles may be weak (as defined by manometry).
Our two phase study will evaluate both symptoms of difficulty swallowing and the vigor with which the esophagus propels a bolus in patients after they 1) receive placebo pills and 2) receive buspirone pills.
We hypothesize that the placebo pills will not affect the vigor of the muscles or the symptoms of difficulty swallowing, but that buspirone will improve both outcomes.
- Being tested
- Buspirone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuspironeDrug
Also called Buspar
PlaceboDrug
Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic
| Study group | Role | What they receive |
|---|---|---|
| Buspirone then Placebo | Experimental | Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks Receives: Drug: Buspirone; Drug: Placebo |
| Placebo then Buspirone | Experimental | Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks. Receives: Drug: Buspirone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry
DCI is a measure of the strength of muscle contractions in the esophagus while swallowing. It is measured in mm Hg, and values greater than 450mm Hg are considered Normal.
Measured: Change in the score from Baseline to 14 days
Secondary outcomes (2)
Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score
A 16-question questionnaire with a score range from 0 to 80, with higher scores indicating worse outcomes (more severe symptoms of GERD).
Measured: Change in the score from Baseline to 14 days
Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.
A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion12 Apr 2017
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional DysphagiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Gabbard, MD, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674412
- Sponsor's protocol ID
- IRB 15-544
- Status last verified
- Jun 2018
- First submitted
- 1 Feb 2016
- Last updated
- 10 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled, Randomized, Double-blind, Cross-over Style Trial of Buspirone in Functional Dysphagia
- ClinicalTrials.gov ID
- NCT02674412
- Acronym / sponsor ID
- IRB 15-544
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Posted 10 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the utility of buspirone in patients who have a diagnosis of functional dysphagia. All participants will be randomized to receive either a placebo pill or buspirone. Subsequently, we will evaluate whether their swallowing is improved. Participants who were randomized to receive placebo will then receive buspirone and those who were receiving buspirone will receive placebo. We will again evaluate whether their swallowing improved.
Detailed description
Buspirone helps to modulate molecules which can affect the activity of the muscles in the esophagus. Studies in the past have shown that in healthy people, buspirone can improve the vigor with which the esophagus squeezes to propel food into the stomach. In patients with functional dysphagia, the esophagus muscles may be weak (as defined by manometry).
Our two phase study will evaluate both symptoms of difficulty swallowing and the vigor with which the esophagus propels a bolus in patients after they 1) receive placebo pills and 2) receive buspirone pills.
We hypothesize that the placebo pills will not affect the vigor of the muscles or the symptoms of difficulty swallowing, but that buspirone will improve both outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buspirone then Placebo | Experimental | Drug: Buspirone, Drug: PlaceboBuspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks |
| Placebo then Buspirone | Experimental | Drug: Buspirone, Drug: PlaceboPlacebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of IEM per Chicago Classification, v3.0 criteria - as noted above
- Esophagogastroduodenoscopy (EGD) negative for mechanical obstruction
- Esophageal biopsies negative for eosinophilic esophagitis
Key exclusion criteria (3 listed)
- Pregnant women
- Prisoners
- Currently on other serotonin modulating medications
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 |
|---|---|---|
| BuspironeAlso: Buspar | Drug | Buspirone then Placebo, Placebo then Buspirone |
| PlaceboPlacebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic | Drug | Buspirone then Placebo, Placebo then Buspirone |
Primary outcome
Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry
Time frame: Change in the score from Baseline to 14 days
DCI is a measure of the strength of muscle contractions in the esophagus while swallowing. It is measured in mm Hg, and values greater than 450mm Hg are considered Normal.
2 secondary outcomes
Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score
Time frame: Change in the score from Baseline to 14 days
Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Buspirone in people with Functional Dysphagia and Ineffective Esophageal Motility, run by The Cleveland Clinic.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry (time frame: Change in the score from Baseline to 14 days). 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 10 Aug 2018; AzTrials last refreshed its copy on 27 Oct 2026.