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Completed

NCT Number: NCT02674412

Buspirone for 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.

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Key information

Conditions

Functional Dysphagia Ineffective Esophageal Motility

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buspirone

Drug

Other names: Buspar

Placebo

Drug

Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 4, 2016
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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