Trial Outcomes & Findings for Buspirone for Functional Dysphagia (NCT NCT02674412)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Change in the score from Baseline to 14 days

Results posted on

2018-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Buspirone Then Placebo Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks	Placebo Then Buspirone Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=10 Participants All participants who enrolled in and completed the study.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=10 Participants
Age, Categorical >=65 years	1 Participants n=10 Participants
Sex: Female, Male Female	7 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=10 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Buspirone n=10 Participants All participants in the study, while taking Buspirone	Placebo n=10 Participants All participants on the study, while taking placebo.
Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry	241.9 mm Hg Standard Deviation 771.7	340.4 mm Hg Standard Deviation 761.7

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Buspirone n=10 Participants All participants in the study, while taking Buspirone	Placebo n=10 Participants All participants on the study, while taking placebo.
Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score	-4.1 Scores on a scale Standard Deviation 22.2	-10.2 Scores on a scale Standard Deviation 16.6

SECONDARY outcome

Timeframe: 14 days

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

Outcome measures

Outcome measures
Measure	Buspirone n=10 Participants All participants in the study, while taking Buspirone	Placebo n=10 Participants All participants on the study, while taking placebo.
Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.	15 percentage of swallows Standard Deviation 37	20 percentage of swallows Standard Deviation 39

Adverse Events

Buspirone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Scott Gabbard, MD

Cleveland Clinic

Phone: 216 444-6523

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place