Buspirone for Functional Dysphagia

Ineffective Esophageal Motility Clinical Trial

Official title:

Placebo-controlled, Randomized, Double-blind, Cross-over Style Trial of Buspirone in Functional Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674412
• Other study ID #: IRB 15-544
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: April 12, 2017

Study information

• Verified date: June 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 12, 2017
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Functional Dysphagia
• Ineffective Esophageal Motility

Intervention

Drug:
• Buspirone

• Placebo
Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Change in the score from Baseline to 14 days
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).	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	14 days