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Buspirone for Functional Dysphagia

Primary Purpose

Functional Dysphagia, Ineffective Esophageal Motility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Buspirone
Placebo
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Buspirone then Placebo

    Placebo then Buspirone

    Arm Description

    Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks

    Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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 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

    Full Information

    First Posted
    February 1, 2016
    Last Updated
    July 10, 2018
    Sponsor
    The Cleveland Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02674412
    Brief Title
    Buspirone for Functional Dysphagia
    Official Title
    Placebo-controlled, Randomized, Double-blind, Cross-over Style Trial of Buspirone in Functional Dysphagia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (Actual)
    Primary Completion Date
    April 12, 2017 (Actual)
    Study Completion Date
    April 12, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Cleveland Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Dysphagia, Ineffective Esophageal Motility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Buspirone then Placebo
    Arm Type
    Experimental
    Arm Description
    Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks
    Arm Title
    Placebo then Buspirone
    Arm Type
    Experimental
    Arm Description
    Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Buspirone
    Other Intervention Name(s)
    Buspar
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic
    Primary Outcome Measure Information:
    Title
    Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry
    Description
    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.
    Time Frame
    Change in the score from Baseline to 14 days
    Secondary Outcome Measure Information:
    Title
    Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score
    Description
    A 16-question questionnaire with a score range from 0 to 80, with higher scores indicating worse outcomes (more severe symptoms of GERD).
    Time Frame
    Change in the score from Baseline to 14 days
    Title
    Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.
    Description
    A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Buspirone for Functional Dysphagia

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