Trial Outcomes & Findings for Buspirone for Early Satiety and Symptoms of Gastroparesis (NCT NCT03587142)

NCT ID: NCT03587142

Last Updated: 2023-06-15

Results Overview

The outcome is assessed using the self-reported early satiety/postprandial fullness subscore (ES/PPF), which is computed as the average of 4 scores for 4-items on the Gastroparesis Cardinal Symptom Index (GCSI) survey: stomach fullness, inability to finish a normal-sized meal, feeling excessively full after meals, and loss of appetite. Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the subscore ranges from 0 to 5. The change is computed as the subscore at 4-weeks minus the baseline subscore.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 96 participants
• Primary outcome timeframe: baseline and 4-weeks
• Results posted on: 2023-06-15

Participant Flow

131 adult participants with gastroparesis or gastroparesis-like 28, symptoms with at least moderately severe symptoms of early satiety and post-prandial fullness and a normal endoscopy were recruited at 6 tertiary clinic sites located in the U.S. between August 2019 and February 2022. The first participant was enrolled August 27, 2019 and the last participant was enrolled February 28, 2022.

Of the 131 participants assessed for eligibility, 96 met eligibility criteria and provided informed consent and were randomized to treatment (47 to Buspirone arm and 49 to Placebo arm).

Participant milestones

Measure	Buspirone Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Overall Study STARTED	47	49
Overall Study COMPLETED	39	39
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Measure	Buspirone Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Overall Study Lost to Follow-up	5	3
Overall Study Did not complete the f4 visit	3	7

Baseline Characteristics

A total of 32 of the 96 patients randomized did not have evaluable data required for the analysis of the intra-gastric meal distribution (16 Buspirone, 16 Placebo patients).

Baseline characteristics by cohort

Measure	Buspirone n=47 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=49 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet	Total n=96 Participants Total of all reporting groups
Age, Continuous	43.0 years STANDARD_DEVIATION 15.8 • n=47 Participants	44.2 years STANDARD_DEVIATION 15.0 • n=49 Participants	43.6 years STANDARD_DEVIATION 15.3 • n=96 Participants
Sex: Female, Male Female	43 Participants n=47 Participants	45 Participants n=49 Participants	88 Participants n=96 Participants
Sex: Female, Male Male	4 Participants n=47 Participants	4 Participants n=49 Participants	8 Participants n=96 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=47 Participants	17 Participants n=49 Participants	30 Participants n=96 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=47 Participants	32 Participants n=49 Participants	66 Participants n=96 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=47 Participants	0 Participants n=49 Participants	0 Participants n=96 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=47 Participants	1 Participants n=49 Participants	1 Participants n=96 Participants
Race (NIH/OMB) Asian	1 Participants n=47 Participants	0 Participants n=49 Participants	1 Participants n=96 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=47 Participants	1 Participants n=49 Participants	1 Participants n=96 Participants
Race (NIH/OMB) Black or African American	2 Participants n=47 Participants	5 Participants n=49 Participants	7 Participants n=96 Participants
Race (NIH/OMB) White	43 Participants n=47 Participants	41 Participants n=49 Participants	84 Participants n=96 Participants
Race (NIH/OMB) More than one race	1 Participants n=47 Participants	0 Participants n=49 Participants	1 Participants n=96 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=47 Participants	1 Participants n=49 Participants	1 Participants n=96 Participants
Married	16 Participants n=47 Participants	21 Participants n=49 Participants	37 Participants n=96 Participants
Diabetes Type 1	3 Participants n=47 Participants	6 Participants n=49 Participants	9 Participants n=96 Participants
Diabetes Type 2	13 Participants n=47 Participants	15 Participants n=49 Participants	28 Participants n=96 Participants
Body Mass Index (BMI)	29.5 kg/m^2 STANDARD_DEVIATION 7.5 • n=47 Participants	29.8 kg/m^2 STANDARD_DEVIATION 7.3 • n=49 Participants	29.7 kg/m^2 STANDARD_DEVIATION 7.4 • n=96 Participants
Overweight to obese (BMI>/=25 kg/m^2)	31 Participants n=47 Participants	37 Participants n=49 Participants	68 Participants n=96 Participants
Weight	78.1 kilogram STANDARD_DEVIATION 21.2 • n=47 Participants	80.2 kilogram STANDARD_DEVIATION 22.2 • n=49 Participants	79.2 kilogram STANDARD_DEVIATION 21.6 • n=96 Participants
Waist circumfence	98.1 centimeter STANDARD_DEVIATION 22.2 • n=47 Participants	98.2 centimeter STANDARD_DEVIATION 19.6 • n=49 Participants	98.1 centimeter STANDARD_DEVIATION 20.8 • n=96 Participants
Proton pump inhibitors	35 Participants n=47 Participants	34 Participants n=49 Participants	69 Participants n=96 Participants
Anxiolytic	1 Participants n=47 Participants	0 Participants n=49 Participants	1 Participants n=96 Participants
Antiemetic	31 Participants n=47 Participants	25 Participants n=49 Participants	56 Participants n=96 Participants
Narcotic (3X/week or less)	2 Participants n=47 Participants	4 Participants n=49 Participants	6 Participants n=96 Participants
Anti-depressant	22 Participants n=47 Participants	22 Participants n=49 Participants	44 Participants n=96 Participants
Neuropathic or pain modulator, anti-seizure, or other psychiatric medication	28 Participants n=47 Participants	31 Participants n=49 Participants	59 Participants n=96 Participants
Gastroparesis Cardinal Symptom Index (GCSI), total score	3.6 units on a scale STANDARD_DEVIATION 0.7 • n=47 Participants	3.5 units on a scale STANDARD_DEVIATION 0.6 • n=49 Participants	3.5 units on a scale STANDARD_DEVIATION 0.6 • n=96 Participants
Nausea/vomiting subscale	2.5 units on a scale STANDARD_DEVIATION 1.3 • n=47 Participants	2.4 units on a scale STANDARD_DEVIATION 1.3 • n=49 Participants	2.5 units on a scale STANDARD_DEVIATION 1.3 • n=96 Participants
Nausea severity	3.6 units on a scale STANDARD_DEVIATION 1.3 • n=47 Participants	3.6 units on a scale STANDARD_DEVIATION 1.2 • n=49 Participants	3.6 units on a scale STANDARD_DEVIATION 1.3 • n=96 Participants
Retching severity	2.1 units on a scale STANDARD_DEVIATION 1.7 • n=47 Participants	1.8 units on a scale STANDARD_DEVIATION 1.6 • n=49 Participants	2.0 units on a scale STANDARD_DEVIATION 1.6 • n=96 Participants
Vomiting severity	1.9 units on a scale STANDARD_DEVIATION 1.8 • n=47 Participants	1.8 units on a scale STANDARD_DEVIATION 1.7 • n=49 Participants	1.8 units on a scale STANDARD_DEVIATION 1.7 • n=96 Participants
Fullness/early satiety subscale	4.0 units on a scale STANDARD_DEVIATION 0.6 • n=47 Participants	4.0 units on a scale STANDARD_DEVIATION 0.6 • n=49 Participants	4.0 units on a scale STANDARD_DEVIATION 0.6 • n=96 Participants
Stomach fullness severity	4.2 units on a scale STANDARD_DEVIATION 0.8 • n=47 Participants	4.2 units on a scale STANDARD_DEVIATION 0.7 • n=49 Participants	4.2 units on a scale STANDARD_DEVIATION 0.7 • n=96 Participants
Unable to finish meal severity	4.0 units on a scale STANDARD_DEVIATION 1.0 • n=47 Participants	4.0 units on a scale STANDARD_DEVIATION 0.9 • n=49 Participants	4.0 units on a scale STANDARD_DEVIATION 0.9 • n=96 Participants
Excessive fullness severity	4.2 units on a scale STANDARD_DEVIATION 0.9 • n=47 Participants	4.3 units on a scale STANDARD_DEVIATION 0.7 • n=49 Participants	4.3 units on a scale STANDARD_DEVIATION 0.8 • n=96 Participants
Loss of appetite severity	3.6 units on a scale STANDARD_DEVIATION 1.3 • n=47 Participants	3.5 units on a scale STANDARD_DEVIATION 1.2 • n=49 Participants	3.5 units on a scale STANDARD_DEVIATION 1.2 • n=96 Participants
Bloating subscale	4.2 units on a scale STANDARD_DEVIATION 1.0 • n=47 Participants	3.9 units on a scale STANDARD_DEVIATION 1.0 • n=49 Participants	4.1 units on a scale STANDARD_DEVIATION 1.0 • n=96 Participants
Bloating severity	4.4 units on a scale STANDARD_DEVIATION 0.9 • n=47 Participants	4.0 units on a scale STANDARD_DEVIATION 1.1 • n=49 Participants	4.2 units on a scale STANDARD_DEVIATION 1.0 • n=96 Participants
Stomach distention severity	4.0 units on a scale STANDARD_DEVIATION 1.2 • n=47 Participants	3.9 units on a scale STANDARD_DEVIATION 1.1 • n=49 Participants	4.0 units on a scale STANDARD_DEVIATION 1.1 • n=96 Participants
Upper abdominal pain subscale	3.3 units on a scale STANDARD_DEVIATION 1.3 • n=47 Participants	3.0 units on a scale STANDARD_DEVIATION 1.2 • n=49 Participants	3.1 units on a scale STANDARD_DEVIATION 1.2 • n=96 Participants
Gastroesophageal Reflux (GERD) subscale	2.1 units on a scale STANDARD_DEVIATION 1.4 • n=47 Participants	2.3 units on a scale STANDARD_DEVIATION 1.2 • n=49 Participants	2.2 units on a scale STANDARD_DEVIATION 1.3 • n=96 Participants
Predominant symptom cluster Excessive fullness	4 Participants n=47 Participants	13 Participants n=49 Participants	17 Participants n=96 Participants
Predominant symptom cluster Early satiety or loss of appetite	2 Participants n=47 Participants	4 Participants n=49 Participants	6 Participants n=96 Participants
Predominant symptom cluster Bloating or distended stomach	14 Participants n=47 Participants	10 Participants n=49 Participants	24 Participants n=96 Participants
Predominant symptom cluster Nausea or vomiting or retching	15 Participants n=47 Participants	13 Participants n=49 Participants	28 Participants n=96 Participants
Predominant symptom cluster Upper abdominal pain or discomfort	5 Participants n=47 Participants	1 Participants n=49 Participants	6 Participants n=96 Participants
Predominant symptom cluster Lower abdominal pain or discomfort	4 Participants n=47 Participants	1 Participants n=49 Participants	5 Participants n=96 Participants
Gastrointestinal Symptom Rating Scale (GSRS)	3.8 units on a scale STANDARD_DEVIATION 1.0 • n=47 Participants	3.7 units on a scale STANDARD_DEVIATION 1.1 • n=49 Participants	3.8 units on a scale STANDARD_DEVIATION 1.0 • n=96 Participants
Patient Health Questionnaire somatization severity scale (PHQ-15)	14.7 units on a scale STANDARD_DEVIATION 5.0 • n=47 Participants	14.9 units on a scale STANDARD_DEVIATION 4.1 • n=49 Participants	14.8 units on a scale STANDARD_DEVIATION 4.5 • n=96 Participants
ANMS Gastroparesis Cardinal Symptom Index Daily Diary Fullness/early satiety subscale	2.62 units on a scale STANDARD_DEVIATION 0.94 • n=47 Participants	2.68 units on a scale STANDARD_DEVIATION 0.86 • n=49 Participants	2.65 units on a scale STANDARD_DEVIATION 0.90 • n=96 Participants
ANMS Gastroparesis Cardinal Symptom Index Daily Diary Early satiety severity	2.56 units on a scale STANDARD_DEVIATION 0.78 • n=47 Participants	2.59 units on a scale STANDARD_DEVIATION 0.86 • n=49 Participants	2.57 units on a scale STANDARD_DEVIATION 0.94 • n=96 Participants
ANMS Gastroparesis Cardinal Symptom Index Daily Diary Excessive fullness severity	2.40 units on a scale STANDARD_DEVIATION 0.98 • n=47 Participants	2.77 units on a scale STANDARD_DEVIATION 0.98 • n=49 Participants	2.74 units on a scale STANDARD_DEVIATION 0.94 • n=96 Participants
PAGI-QOL disease-specific Quality of Life (QOL) Total Score	2.3 units on a scale STANDARD_DEVIATION 1.1 • n=47 Participants	2.4 units on a scale STANDARD_DEVIATION 1.1 • n=49 Participants	2.4 units on a scale STANDARD_DEVIATION 1.1 • n=96 Participants
Hospital Anxiety and Depression Scale (HADS) HADS-A total score	9.3 units on a scale STANDARD_DEVIATION 4.5 • n=47 Participants	9.1 units on a scale STANDARD_DEVIATION 4.8 • n=49 Participants	9.2 units on a scale STANDARD_DEVIATION 4.6 • n=96 Participants
Hospital Anxiety and Depression Scale (HADS) HADS-D total score	6.7 units on a scale STANDARD_DEVIATION 5.1 • n=47 Participants	6.8 units on a scale STANDARD_DEVIATION 4.7 • n=49 Participants	6.8 units on a scale STANDARD_DEVIATION 4.9 • n=96 Participants
SF-36 Quality of Life (QOL) Physical component summary score	33.7 units on a scale STANDARD_DEVIATION 8.2 • n=47 Participants	33.3 units on a scale STANDARD_DEVIATION 9.0 • n=49 Participants	33.5 units on a scale STANDARD_DEVIATION 8.6 • n=96 Participants
SF-36 Quality of Life (QOL) Mental component summary score	37.9 units on a scale STANDARD_DEVIATION 15.6 • n=47 Participants	41.3 units on a scale STANDARD_DEVIATION 13.8 • n=49 Participants	39.6 units on a scale STANDARD_DEVIATION 14.7 • n=96 Participants
Gastric Emptying scintigraphy (GES) Not delayed gastric emptying	20 Participants n=47 Participants	25 Participants n=49 Participants	45 Participants n=96 Participants
Gastric Emptying scintigraphy (GES) Delayed gastric emptying	26 Participants n=47 Participants	22 Participants n=49 Participants	48 Participants n=96 Participants
Gastric Emptying scintigraphy (GES) Rapid gastric emptying	1 Participants n=47 Participants	2 Participants n=49 Participants	3 Participants n=96 Participants
Intra-gastric meal distribution (IMD) Normal (0.644 - 1.00)	27 Participants n=31 Participants • A total of 32 of the 96 patients randomized did not have evaluable data required for the analysis of the intra-gastric meal distribution (16 Buspirone, 16 Placebo patients).	25 Participants n=33 Participants • A total of 32 of the 96 patients randomized did not have evaluable data required for the analysis of the intra-gastric meal distribution (16 Buspirone, 16 Placebo patients).	52 Participants n=64 Participants • A total of 32 of the 96 patients randomized did not have evaluable data required for the analysis of the intra-gastric meal distribution (16 Buspirone, 16 Placebo patients).
Intra-gastric meal distribution (IMD) Borderline (0.568 - 0.643)	0 Participants n=31 Participants • A total of 32 of the 96 patients randomized did not have evaluable data required for the analysis of the intra-gastric meal distribution (16 Buspirone, 16 Placebo patients).	3 Participants n=33 Participants • A total of 32 of the 96 patients randomized did not have evaluable data required for the analysis of the intra-gastric meal distribution (16 Buspirone, 16 Placebo patients).	3 Participants n=64 Participants • A total of 32 of the 96 patients randomized did not have evaluable data required for the analysis of the intra-gastric meal distribution (16 Buspirone, 16 Placebo patients).
Intra-gastric meal distribution (IMD) Impaired (<0.568)	4 Participants n=31 Participants • A total of 32 of the 96 patients randomized did not have evaluable data required for the analysis of the intra-gastric meal distribution (16 Buspirone, 16 Placebo patients).	5 Participants n=33 Participants • A total of 32 of the 96 patients randomized did not have evaluable data required for the analysis of the intra-gastric meal distribution (16 Buspirone, 16 Placebo patients).	9 Participants n=64 Participants • A total of 32 of the 96 patients randomized did not have evaluable data required for the analysis of the intra-gastric meal distribution (16 Buspirone, 16 Placebo patients).
Water load test, volume consumed	415.9 mL STANDARD_DEVIATION 217.0 • n=47 Participants	401.7 mL STANDARD_DEVIATION 198.0 • n=49 Participants	408.5 mL STANDARD_DEVIATION 206.3 • n=96 Participants
Water load test, consumed low volume (<238 mL)	9 Participants n=47 Participants	10 Participants n=49 Participants	19 Participants n=96 Participants

PRIMARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with data for the outcome available at 4-weeks.

The outcome is assessed using the self-reported early satiety/postprandial fullness subscore (ES/PPF), which is computed as the average of 4 scores for 4-items on the Gastroparesis Cardinal Symptom Index (GCSI) survey: stomach fullness, inability to finish a normal-sized meal, feeling excessively full after meals, and loss of appetite. Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the subscore ranges from 0 to 5. The change is computed as the subscore at 4-weeks minus the baseline subscore.

Outcome measures

Measure	Buspirone n=47 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=49 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in the Postprandial Fullness and Early Satiety Symptoms Severity	-1.16 score on a scale Standard Deviation 1.25	-1.03 score on a scale Standard Deviation 1.19

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with 4-week visit data

The outcome is assessed using self-reported assessment of stomach fullness severity in the prior 2-weeks using the Gastroparesis Cardinal Symptoms Index (GCSI) survey. The item is scored from 0 (no) to 5 (very severe) symptoms; the change is computed as the score at 4-weeks minus the baseline score.

Outcome measures

Measure	Buspirone n=47 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=47 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Stomach Fullness Symptom Severity	-1.16 score on a scale Standard Deviation 1.55	-1.07 score on a scale Standard Deviation 1.34

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and data for excessive fullness severity.

The outcome is assessed using self-reported assessment of feeling excessively full after meals severity in the prior 2-weeks using the Gastroparesis Cardinal Symptom Index (GCSI) survey. The item is scored from 0 (no) to 5 (very severe) symptoms; the change is computed as the score at 4-weeks minus the baseline score.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Excessive Fullness Symptom Severity	-1.14 score on a scale Standard Deviation 1.56	-0.99 score on a scale Standard Deviation 1.30

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit.

The outcome is assessed using self-reported assessment of inability to finish a normal-sized meal severity in the prior 2-weeks using the Gastroparesis Cardinal Symptom Index (GCSI) survey. The item is scored from 0 (no) to 5 (very severe) symptoms; the change is computed as the score at 4-weeks minus the baseline score. A negative change indicates symptom improvement.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Inability to Finish a Normal-sized Meal Symptom Severity	-1.27 score on a scale Standard Deviation 1.55	-1.12 score on a scale Standard Deviation 1.63

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and values for loss of appetite severity.

The outcome is assessed using self-reported assessment of loss of appetite severity in the prior 2-weeks using the Gastroparesis Cardinal Symptom Index (GCSI) survey. The item is scored from 0 (no) to 5 (very severe) symptoms; the change is computed as the score at 4-weeks minus the baseline score. A negative change indicates symptom improvement.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Loss of Appetite Symptom Severity	-1.09 score on a scale Standard Deviation 1.64	-0.96 score on a scale Standard Deviation 1.62

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All patients with 4-week visit data for GCSI.

The outcome is assessed using the self-reported Gastroparesis Cardinal Symptom Index (GCSI) total score, which is computed as the average of the 3 subscores on the GCSI survey: 3-item early satiety/postprandial fullness subscore, the nausea/vomiting subscore (average of 3-items: nausea, retching, vomiting), and bloating subscore (average of 2-items: bloating, stomach visibly larger). Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the total score ranges from 0 to 5. The change is computed as the total score at 4-weeks minus the baseline total score. A negative change indicates improved symptoms.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Total Overall GCSI Symptom Severity	-1.06 score on a scale Standard Deviation 1.16	-0.86 score on a scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and data for the nausea/vomiting subscore.

The outcome is assessed using the self-reported nausea/vomiting subscore, which is computed as the average of 3 scores for 3-items on the Gastrointestinal Cardinal Symptom Index (GCSI) survey: nausea, retching, vomiting. Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks. The change is computed as the subscore at 4-weeks minus the baseline subscore. Negative change indicates improvement in symptoms.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Nausea, Vomiting and Retching Symptoms Severity	-0.65 score on a scale Standard Deviation 1.40	-0.60 score on a scale Standard Deviation 1.26

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and data for the nausea severity.

The outcome is assessed using self-reported assessment of nausea severity item from the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) in the prior 2-weeks using the Gastroparesis Cardinal Symptom Index (GCSI) survey. The item is scored from 0 (no) to 5 (very severe) symptoms; the change is computed as the score at 4-weeks minus the baseline score.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Nausea Symptom Severity	-0.75 score on a scale Standard Deviation 1.40	-0.70 score on a scale Standard Deviation 1.51

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and data for vomiting severity.

The outcome is assessed using self-reported assessment of vomiting severity in the prior 2-weeks using the Gastroparesis Cardinal Symptom Index (GCSI) survey. The item is scored from 0 (no) to 5 (very severe) symptoms; the change is computed as the score at 4-weeks minus the baseline score. A negative change indicates improvement in vomiting severity.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Vomiting Symptom Severity	-0.71 score on a scale Standard Deviation 1.81	-0.57 score on a scale Standard Deviation 1.47

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit data for the bloating subscore.

The outcome is assessed using the self-reported bloating subscore, which is computed as the average of 2 scores for 2-items on the Gastroparesis Cardinal Symptom Index (GCSI) survey: bloating, stomach visibly larger. Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the subscore ranges from 0 to 5. The change is computed as the subscore at 4-weeks minus the baseline subscore. A negative value for change indicates improvement in symptoms.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Bloating and Stomach Distention Symptoms Severity	-1.36 score on a scale Standard Deviation 1.42	-0.95 score on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the treatment arm with a 4-week visit and data for bloating severity.

The outcome is assessed using self-reported assessment of bloating severity in the prior 2-weeks using the Gastroparesis Cardinal Symptom Index (GCSI) survey. The item is scored from 0 (no) to 5 (very severe) symptoms; the change is computed as the score at 4-weeks minus the baseline score. A negative change indicates symptom improvement.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Bloating Symptom Severity	-1.34 score on a scale Standard Deviation 1.46	-0.69 score on a scale Standard Deviation 1.18

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and values for the upper abdominal pain subscore.

The outcome is assessed using the self-reported upper abdominal pain subscore, which is computed as the average of 2 scores for 2-items on the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) survey: upper abdominal pain, upper abdominal discomfort. Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the subscore ranges from 0 to 5. The change is computed as the subscore at 4-weeks minus the baseline subscore.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Upper Abdominal Pain and Discomfort Symptoms Severity	-0.78 score on a scale Standard Deviation 1.55	-0.95 score on a scale Standard Deviation 1.63

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and upper abdominal pain severity data.

The outcome is assessed using self-reported assessment of upper abdominal pain severity in the prior 2-weeks using the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) survey. The item is scored from 0 (no) to 5 (very severe) symptoms; the change is computed as the score at 4-weeks minus the baseline score. A negative change indicates symptom improvement.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Upper Abdominal Pain Symptom Severity	-0.69 score on a scale Standard Deviation 1.73	-0.93 score on a scale Standard Deviation 1.63

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with 4-week visit data for the GERD subscore.

The outcome is assessed using the self-reported GERD subscore, which is computed as the average of 7 scores for 7-items on the Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) survey: heartburn during the day, heartburn when lying down, feeling of discomfort inside chest during the day, feeling of discomfort inside chest during sleep, regurgitation or reflux during the day, regurgitation when lying down, bitter, acid or sour taste in mouth. Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the subscore ranges from 0 to 5. The change is computed as the subscore at 4-weeks minus the baseline subscore.

Outcome measures

Measure	Buspirone n=38 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Gastroesophageal (GERD) Symptoms Severity	-0.36 score on a scale Standard Deviation 1.44	-0.45 score on a scale Standard Deviation 1.01

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and data for the GSRS total score.

The outcome is assessed using the self-reported GSRS total score which is computed as the mean of the 15 item scores on the Gastrointestinal Symptom Rating Scale (GSRS) survey. Each item is scored from 1 (no discomfort) to 7 (very severe discomfort) of the symptom in the past week. The change is computed as the score at 4-weeks minus the baseline score. A negative change indicates symptom improvement.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=38 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Gastrointestinal Symptoms Rating Scale (GSRS) Global Score	-0.63 units on a scale Standard Deviation 1.09	-0.49 units on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and data for CPGAS score.

The outcome is assessed using the participant-rated Clinical Patient Grading Assessment Scale (CPGAS) score which is scored from -3 (very considerably worse) to 3 (completely better) in the past week compared to the way the participant usually feels. The change is computed as the score at 4-weeks minus the baseline score. A positive change indicates patient feeling better.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Participant's Rating of Symptom Relief	0.69 units on a scale Standard Deviation 1.03	0.37 units on a scale Standard Deviation 1.10

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: Participants in each arm with the total somatization score at 4-weeks.

The outcome is assessed using the self-reported Patient Health Questionnaire 15 Somatic Symptom Severity Scale (PHQ-15) total somatization score (ranges from 0 -30, with 30 being most bothered by symptoms in prior 4-weeks), calculated as the sum of 15-items, each scored from 0 (not bothered at all) to 2 (bothered a lot) by somatic symptoms in the prior 4-weeks. The change is computed as the score at 4-weeks minus the baseline score. A negative change indicates being less bothered by the symptoms.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Severity of Somatic Symptoms	-0.99 units on a scale Standard Deviation 3.88	-2.00 units on a scale Standard Deviation 3.93

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: Participants in each arm with HADS data at 4-weeks. 1 Placebo patient did not have HADS data at 4-weeks.

The outcome is assessed using the self-reported Hospital Anxiety and Depression Scale (HADS) depression subscore, calculated as the sum of 7 items, each scored from 0 (not at all) to 3 (most of the time). The change is computed as the subscore at 4-weeks minus the baseline subscore. A negative change indicates reduced depression.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=38 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Depression	0.42 units on a scale Standard Deviation 4.06	-1.43 units on a scale Standard Deviation 3.91

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: Participants in each arm with HADS anxiety data at 4-weeks. 1 Placebo patient did not report a HADS anxiety subscale score at 4 -weeks.

The outcome is assessed using the self-reported Hospital Anxiety and Depression Scale (HADS) anxiety subscore, calculated as the sum of 7-items, each scored from 0 (not at all) to 3 (most of the time). The change is computed as the subscore at 4-weeks minus the baseline subscore. A negative change indicates reduced anxiety at 4-weeks.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=38 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Anxiety	-1.27 units on a scale Standard Deviation 4.82	-2.03 units on a scale Standard Deviation 3.94

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: Participants with available PAGI-QOL data at 4-weeks. 1 Placebo patient did not have values for PAGI-QOL total score.

The outcome is assessed using the self-reported Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) total score which comprises 30 items scored from 0 (none of the time) to 5 (all of the time) the participant's QOL has been affected by their gastrointestinal issues in the prior two weeks. The total score is the mean of the 5 subscale scores and ranges from 0 (lowest QOL) to 5 (highest QOL) in past 2-weeks. The change is computed as the score at 4-weeks minus the baseline score. A positive change indicates improved QOL.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=38 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change Overall Quality of Health Due to Gastroparesis Issues	0.43 score on a scale Standard Deviation 0.81	0.64 score on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants in the treatment arm with baseline and mental QOL data at 4-weeks.

The outcome is assessed using the self-reported 36-item Short Form Health Survey (SF-36v2) mental health QOL component score. The score ranges from 0 (poorest) to 100 (highest) QOL. The change is computed as the score at 4-weeks minus the baseline score. A positive change indicates improved mental QOL.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Overall Mental Quality of Life (QOL)	1.19 units on a scale Standard Deviation 10.54	3.17 units on a scale Standard Deviation 11.83

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and data for the Physical QOL summary score.

The outcome is assessed using the self-reported 36-item Short Form Health Survey (SF-36v2) physical health QOL component score. The score ranges from 0 (poorest) to 100 (highest) QOL. The change is computed as the score at 4-weeks minus the baseline score. A positive change indicates improved Physical QOL.

Outcome measures

Measure	Buspirone n=39 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=39 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Overall Physical Quality of Life (QOL)	1.10 units on a scale Standard Deviation 7.18	3.17 units on a scale Standard Deviation 5.95

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm that had 4 week visit data for the GES test at 4-hours.

The outcome is assessed using the percent of gastric retention at 4-hours from the Gastric Emptying Scintigraphy (GES) test. The change is computed as the percent retention at 4-weeks minus the baseline percent retention. % retention is the amount of food remaining in the stomach at 4-hours of the GES test and ranges from 0% (no food) to 100% (all of the food).

Outcome measures

Measure	Buspirone n=26 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=33 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Gastric Retention	4.24 units on a percentage scale Standard Deviation 21.19	2.87 units on a percentage scale Standard Deviation 21.8

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: Patients in each treatment arm with measurements for IMD at 4-weeks.

The Intragastric meal distribution (IMD) is assessed at baseline and 4-weeks during the Gastric Emptying Scintigraphy Test. The ratio of gastric counts of the meal in the proximal stomach to the distal stomach is used to compute the Intragastric meal distribution (IMD) which can be used as an indirect measure of Fundic Accommodation.

Outcome measures

Measure	Buspirone n=17 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=24 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Change at 4-weeks in the Intragastric Meal Distribution (IMD)	-0.04 ratio Standard Deviation 0.13	0.02 ratio Standard Deviation 0.13

SECONDARY outcome

Timeframe: baseline and 4-weeks

Population: Participants in each treatment arm with a volume of water measured at both baseline and 4-weeks.

The Water Load Satiety Test (WLST) is the amount of water a patient can consume until full in 5 minutes. The volume of water is recorded. The change is computed as the volume of water ingested at baseline subtracted from the amount of water ingested at 4-weeks. A positive change indicates that the patient can ingest more water at 4-weeks than at baseline.

Outcome measures

Measure	Buspirone n=26 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=26 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Change From Baseline at 4-weeks in the Water Load Satiety Test (WLST)	-43.3 ml Standard Error 219.1	-21.8 ml Standard Error 145.6

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and a measurement for weight.

This safety outcome is computed by subtracting the weight (kg) at baseline from the weight (kg) at 4-weeks

Outcome measures

Measure	Buspirone n=26 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=29 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Weight	-0.34 kilogram Standard Deviation 1.36	-0.43 kilogram Standard Deviation 1.99

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with 4-week visit data for the Electrocardiogram QTc interval.

This safety outcome is computed from the results of an electrocardiogram (ECG) QTc interval at 4-weeks measured in milliseconds (msec).

Outcome measures

Measure	Buspirone n=26 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=29 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Cardiac Rhythm	-2.80 milliseconds (msec) Standard Deviation 19.18	3.63 milliseconds (msec) Standard Deviation 23.42

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and a measurement for ALT.

This safety outcome is computed by subtracting the baseline level of Alanine Aminotransferase (ALT) (U/L) from the 4-week level.

Outcome measures

Measure	Buspirone n=28 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=33 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Aspartate Aminotransferase (ALT)	0.32 U/L Standard Deviation 15.93	1.34 U/L Standard Deviation 9.57

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit and a measurement for Creatinine.

This safety outcome is computed by subtracting the baseline level of creatinine (mg/dL) from the 4-week level.

Outcome measures

Measure	Buspirone n=27 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=33 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Creatinine	0.02 mg/dL Standard Deviation 0.07	-0.01 mg/dL Standard Deviation 0.11

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 4-weeks

Population: All participants assigned to the arm with a 4-week visit with a measurement for glucose.

This safety outcome is computed by subtracting the baseline level of glucose (mg/dL) from the 4-week level.

Outcome measures

Measure	Buspirone n=27 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=33 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
4-Week Change in Fasting Glucose	10.30 mg/dL Standard Deviation 38.10	10.69 mg/dL Standard Deviation 42.21

OTHER_PRE_SPECIFIED outcome

Timeframe: over 4-weeks

This safety outcome is the frequency over the 4-weeks of the study of all reported adverse events using the v5.0 CTCAE classification system.

Outcome measures

Measure	Buspirone n=47 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=49 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Assessment of Adverse Events Over 4-Weeks	12 events	8 events

OTHER_PRE_SPECIFIED outcome

Timeframe: over 4-weeks

Population: All participants randomized in the trial with events occurring over the 4 weeks of follow-up.

This safety outcome is the frequency over the 4-weeks of the study of all reported adverse events' severity grade as classified by the NCI's Common Terminology Criteria for Adverse Events (CTCAE v5.0). For the patient with 2 AE's, the AE with the maximum severity is reported.

Outcome measures

Measure	Buspirone n=47 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=49 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Assessment of the Severity of Adverse Events Over 4-Weeks 3-severe	1 Participants	0 Participants
Assessment of the Severity of Adverse Events Over 4-Weeks 4-life threatening	0 Participants	0 Participants
Assessment of the Severity of Adverse Events Over 4-Weeks 5-death	0 Participants	0 Participants
Assessment of the Severity of Adverse Events Over 4-Weeks No Adverse events	35 Participants	41 Participants
Assessment of the Severity of Adverse Events Over 4-Weeks 1-mild severity	5 Participants	2 Participants
Assessment of the Severity of Adverse Events Over 4-Weeks 2-moderate severity	6 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: over 4 weeks of treatment

Population: All patients randomized into each treatment arm

Serious Adverse Event (SAE) defined by the FDA as an event meeting one or more of the following criteria; inpatient hospitalization or prolonged existing hospitalization; persistent or significant incapacity or substantial disruption of ability to conduct normal life functions; jeopardized patient and required medical or surgical intervention to prevent a serious event; or congenital anomaly or birth defect.

Outcome measures

Measure	Buspirone n=47 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=49 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Serious Adverse Events	1 Serious adverse events	1 Serious adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: over the 4-weeks of the trial

Population: all participants by treatment arm randomized into the trial

Hospitalization events by treatment arm were reported on the Adverse Event Case-Report form at each visit and also at time of occurrence and tabulated at end of treatment visit for comparison between placebo and buspirone arms.

Outcome measures

Measure	Buspirone n=47 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=49 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Total Number of Hospitalizations Over 4-weeks of Treatment	1 hospitalizations	0 hospitalizations

OTHER_PRE_SPECIFIED outcome

Timeframe: over 4-weeks of treatment

Population: All patients randomized into each treatment group.

Adverse events were reported on the Adverse Event Report form by the principal investigator at each clinic site using the CTCAE v5 classification system.

Outcome measures

Measure	Buspirone n=47 Participants Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=49 Participants Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Adverse Events by Body Classification System by Treatment Group During the Trial Gastrointestinal	3 events by body classification	3 events by body classification
Adverse Events by Body Classification System by Treatment Group During the Trial Immune system	1 events by body classification	0 events by body classification
Adverse Events by Body Classification System by Treatment Group During the Trial Metabolic & nutrition	1 events by body classification	0 events by body classification
Adverse Events by Body Classification System by Treatment Group During the Trial Nervous system	3 events by body classification	0 events by body classification
Adverse Events by Body Classification System by Treatment Group During the Trial Renal & urinary	1 events by body classification	1 events by body classification
Adverse Events by Body Classification System by Treatment Group During the Trial Surgical & medical	0 events by body classification	1 events by body classification
Adverse Events by Body Classification System by Treatment Group During the Trial Musculoskeletal & connective tissue disorders	0 events by body classification	1 events by body classification
Adverse Events by Body Classification System by Treatment Group During the Trial Total	12 events by body classification	9 events by body classification
Adverse Events by Body Classification System by Treatment Group During the Trial Infections & infestations	3 events by body classification	1 events by body classification
Adverse Events by Body Classification System by Treatment Group During the Trial Investigations	0 events by body classification	2 events by body classification

Adverse Events

Buspirone

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Buspirone n=47 participants at risk Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=49 participants at risk Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Surgical and medical procedures neurostimulator implantation	0.00% 0/47 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).	2.0% 1/49 • Number of events 1 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).
Immune system disorders severe allergic reaction	2.1% 1/47 • Number of events 1 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).	0.00% 0/49 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).

Other adverse events

Measure	Buspirone n=47 participants at risk Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Buspirone: Buspirone tablet	Placebo n=49 participants at risk Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Placebo: "Sugar" pill manufactured to mimic buspirone 10 mg tablet
Gastrointestinal disorders Nausea, vomiting, retching	6.4% 3/47 • Number of events 3 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).	4.1% 2/49 • Number of events 3 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).
Infections and infestations upper respiratory & sinus infection	6.4% 3/47 • Number of events 3 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).	2.0% 1/49 • Number of events 1 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).
Investigations QTC interval was high	0.00% 0/47 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).	4.1% 2/49 • Number of events 2 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).
Metabolism and nutrition disorders Worsening of a comorbid illness	2.1% 1/47 • Number of events 1 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).	0.00% 0/49 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).
Nervous system disorders Episodes of dizziness and somnolence	6.4% 3/47 • Number of events 3 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).	0.00% 0/49 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).
Renal and urinary disorders urinary tract infection & renal calculi	2.1% 1/47 • Number of events 1 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).	2.0% 1/49 • Number of events 1 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/47 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).	2.0% 1/49 • Number of events 1 • Adverse events were counted after randomization through end of treatment at 4-weeks. Adverse events coded for severity grade using the NCI's Common Terminology Criteria for Adverse Events (v5.0 CTCAE).

Additional Information

Dr. Henry Parkman

Temple University

Phone: (215) 707-7579

Email: henry.parkman@temple.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place