Buspirone for Functional Dysphagia

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02674412
• Collaborator: (none)
• Enrollment: 10
• Arms: 2
• Actual Duration (Months): 14.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Functional Dysphagia; Ineffective Esophageal Motility	Drug: Buspirone; Drug: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Placebo-controlled, Randomized, Double-blind, Cross-over Style Trial of Buspirone in Functional Dysphagia
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Apr 12, 2017
• Actual Study Completion Date: Apr 12, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry [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 Outcome Measures

1. Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score [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. [14 days]

   A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 10, 2016

More Information

Publications

None provided.

• Responsible Party: Scott Gabbard, MD, MD, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02674412
• Other Study ID Numbers: IRB 15-544
• First Posted: Feb 4, 2016
• Last Update Posted: Aug 10, 2018
• Last Verified: Jun 1, 2018

• Additional relevant MeSH terms: Deglutition Disorders; Buspirone

Study Results

Participant Flow

Arm/Group Title	Buspirone Then Placebo	Placebo Then Buspirone
Arm/Group 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.
Period Title: Overall Study
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	All participants who enrolled in and completed the study.
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 90%
>=65 years	1 10%
Sex: Female, Male (Count of Participants)
Female	7 70%
Male	3 30%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Buspirone	Placebo
Arm/Group Description	All participants in the study, while taking Buspirone	All participants on the study, while taking placebo.
Measure Participants	10	10
Mean (Standard Deviation) [mm Hg]	241.9 (771.7)	340.4 (761.7)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Buspirone	Placebo
Arm/Group Description	All participants in the study, while taking Buspirone	All participants in the study, while taking placebo
Measure Participants	10	10
Mean (Standard Deviation) [Scores on a scale]	-4.1 (22.2)	-10.2 (16.6)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Buspirone	Placebo
Arm/Group Description	All participants in the study, while taking Buspirone	All participants in the study, while taking placebo
Measure Participants	10	10
Mean (Standard Deviation) [percentage of swallows]	15 (37)	20 (39)

Adverse Events

Time Frame	Six Weeks
Arm/Group Title	Buspirone		Placebo
Arm/Group Description	Buspirone 10 mg PO TID Buspirone		Placebo Tablet TID Placebo: Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic
All Cause Mortality
	Buspirone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Buspirone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Buspirone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.