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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buspirone | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change in the score from Baseline to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Change in the score from Baseline to 14 days |
| Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Buspirone Then Placebo | Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks |
| FG001 | Placebo Then Buspirone | Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis was performed for each subject during two separate periods--once while on Buspirone and once while on Placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants who enrolled in and completed the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mm Hg | Change in the score from Baseline to 14 days |
|
Six Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buspirone | Buspirone 10 mg PO TID Buspirone | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Gabbard, MD | Cleveland Clinic | 216 444-6523 | gabbars@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2016 | Jul 10, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002065 | Buspirone |
| ID | Term |
|---|---|
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic |
|
A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg |
| 14 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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). | Posted | Mean | Standard Deviation | Scores on a scale | Change in the score from Baseline to 14 days |
|
|
|
| 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 | Posted | Mean | Standard Deviation | percentage of swallows | 14 days |
|
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Placebo | Placebo Tablet TID Placebo: Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic | 0 | 10 | 0 | 10 | 0 | 10 |
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| D010879 |
| Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011083 | Polycyclic Compounds |