Buspirone for Functional Dysphagia

NCT02674412 | Completed Results

• 1 other identifier: IRB 15-544
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Functional Dysphagia; Ineffective Esophageal Motility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score

  Change in the score from Baseline to 14 days

• Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.

  14 days

Study Arms (2)

Buspirone then Placebo

EXPERIMENTAL

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

Drug: Buspirone; Drug: Placebo

Placebo then Buspirone

EXPERIMENTAL

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

Drug: Buspirone; Drug: Placebo

Interventions

Buspirone DRUG

Also known as: Buspar

Buspirone then Placebo; Placebo then Buspirone

Placebo DRUG

Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic

Buspirone then Placebo; Placebo then Buspirone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of IEM per Chicago Classification, v3.0 criteria - as noted above
• Esophagogastroduodenoscopy (EGD) negative for mechanical obstruction
• Esophageal biopsies negative for eosinophilic esophagitis

You may not qualify if:

• Pregnant women
• Prisoners
• Currently on other serotonin modulating medications

Sponsors & Collaborators

• The Cleveland Clinic: lead

MeSH Terms

Interventions

Buspirone

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Results Point of Contact

• Title: Scott Gabbard, MD
• Organization: Cleveland Clinic

gabbars@ccf.org

216 444-6523

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 4, 2016
• Study Start: February 1, 2016
• Primary Completion: April 12, 2017
• Study Completion: April 12, 2017
• Last Updated: August 10, 2018
• Results First Posted: August 10, 2018

Record last verified: 2018-06