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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.
Details
| Lead sponsor | The Cleveland Clinic |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 10 |
| Start date | 2016-02 |
| Completion | 2017-04-12 |
Conditions
- Functional Dysphagia
- Ineffective Esophageal Motility
Interventions
- Buspirone
- Placebo
Primary outcomes
- 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.