Buspirone for Functional Dysphagia

Not Applicable

Completed

• Conditions: Ineffective Esophageal Motility; Functional Dysphagia
• Interventions: Drug: Buspirone; Drug: Placebo

• Registration Number: NCT02674412
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-04
• Primary Completion: 2017-04-12
• Study Completion: 2017-04-12
• Status Verified: 2018-06
• Results First Submitted: 2018-06-14
• Results First Submitted QC: 2018-07-10
• Last Update Submitted: 2018-07-10
• Results First Posted: 2018-08-10
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Buspirone then Placebo	Placebo	Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks
Placebo then Buspirone	Buspirone	Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.
Placebo then Buspirone	Placebo	Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.
Buspirone then Placebo	Buspirone	Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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).