N/A
N=10
Buspirone for Functional Dysphagia
Functional Dysphagia · Ineffective Esophageal Motility
Bottom Line
View on ClinicalTrials.gov: NCT02674412 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry — 241.9; 340.4 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Buspirone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry |
241.9; 340.4 | — |
| SECONDARY Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score |
-4.1; -10.2 | — |
| SECONDARY Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows. |
15; 20 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02674412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.