Buspirone for Functional Dysphagia

July 10, 2018 updated by: Scott Gabbard, MD, The Cleveland Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Buspirone then Placebo
Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks
Drug: Buspirone
Other Names:
  • Buspar
Drug: Placebo
Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic
EXPERIMENTAL: Placebo then Buspirone
Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.
Drug: Buspirone
Other Names:
  • Buspar
Drug: Placebo
Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry
Time Frame: 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.
Change in the score from Baseline to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score
Time Frame: 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).
Change in the score from Baseline to 14 days
Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.
Time Frame: 14 days
A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

April 12, 2017

Study Completion (ACTUAL)

April 12, 2017

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (ESTIMATE)

February 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 15-544

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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