Functional Dysphagia, Ineffective Esophageal Motility
Conditions
Brief 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. 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.
Interventions
DRUGBuspirone
DRUGPlacebo
Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of IEM per Chicago Classification, v3.0 criteria - as noted above * Esophagogastroduodenoscopy (EGD) negative for mechanical obstruction * Esophageal biopsies negative for eosinophilic esophagitis
Exclusion criteria
* Pregnant women * Prisoners * Currently on other serotonin modulating medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score | Change in the score from Baseline to 14 days | A 16-question questionnaire with a score range from 0 to 80, with higher scores indicating worse outcomes (more severe symptoms of GERD). |
| Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows. | 14 days | A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants who enrolled in and completed the study. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Time frame: Change in the score from Baseline to 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buspirone | Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry | 241.9 mm Hg | Standard Deviation 771.7 |
| Placebo | Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry | 340.4 mm Hg | Standard Deviation 761.7 |
Secondary
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).
Time frame: Change in the score from Baseline to 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buspirone | Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score | -4.1 Scores on a scale | Standard Deviation 22.2 |
| Placebo | Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score | -10.2 Scores on a scale | Standard Deviation 16.6 |
Secondary
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
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buspirone | Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows. | 15 percentage of swallows | Standard Deviation 37 |
| Placebo | Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows. | 20 percentage of swallows | Standard Deviation 39 |