Trial · NCT03587142

Buspirone for Early Satiety and Symptoms of Gastroparesis

NCT03587142, Phase 2, Completed, Johns Hopkins Bloomberg School of Public Health; results first posted 2023-06-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Buspirone for Early Satiety and Symptoms of Gastroparesis. Trials, record NCT03587142. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03587142

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Buspirone for Early Satiety and Symptoms of Gastroparesis
NCT number: NCT03587142
Status: Completed
Phases: Phase 2
Enrollment: 96 participants, actual
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Conditions: Gastroparesis
Interventions: Buspirone, Placebo
First posted: 2018-07-16
Last updated: 2023-06-15
Results first posted: 2023-06-15

Source ClinicalTrials.gov

Registered outcomes35

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	4-Week Change in the Postprandial Fullness and Early Satiety Symptoms Severity	baseline and 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.
Secondary	4-Week Change in Stomach Fullness Symptom Severity	baseline and 4-weeks	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.
Secondary	4-Week Change in Excessive Fullness Symptom Severity	baseline and 4-weeks	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.
Secondary	4-Week Change in Inability to Finish a Normal-sized Meal Symptom Severity	baseline and 4-weeks	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.
Secondary	4-Week Change in Loss of Appetite Symptom Severity	baseline and 4-weeks	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.
Secondary	4-Week Change in Total Overall GCSI Symptom Severity	baseline and 4-weeks	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.
Secondary	4-Week Change in Nausea, Vomiting and Retching Symptoms Severity	baseline and 4-weeks	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.
Secondary	4-Week Change in Nausea Symptom Severity	baseline and 4-weeks	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.
Secondary	4-Week Change in Vomiting Symptom Severity	baseline and 4-weeks	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.
Secondary	4-Week Change in Bloating and Stomach Distention Symptoms Severity	baseline and 4-weeks	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.

1 to 10 of 35Source ClinicalTrials.gov

See all 35 registered outcomes

Outcomes35

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	4-Week Change in the Postprandial Fullness and Early Satiety Symptoms Severity	baseline and 4-weeks	All participants assigned to the arm with data for the outcome available at 4-weeks.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	4-Week Change in Stomach Fullness Symptom Severity	baseline and 4-weeks	All participants assigned to the arm with 4-week visit data	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	4-Week Change in Excessive Fullness Symptom Severity	baseline and 4-weeks	All participants assigned to the arm with a 4-week visit and data for excessive fullness severity.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	4-Week Change in Inability to Finish a Normal-sized Meal Symptom Severity	baseline and 4-weeks	All participants assigned to the arm with a 4-week visit.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	4-Week Change in Loss of Appetite Symptom Severity	baseline and 4-weeks	All participants assigned to the arm with a 4-week visit and values for loss of appetite severity.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	4-Week Change in Total Overall GCSI Symptom Severity	baseline and 4-weeks	All patients with 4-week visit data for GCSI.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	4-Week Change in Nausea, Vomiting and Retching Symptoms Severity	baseline and 4-weeks	All participants assigned to the arm with a 4-week visit and data for the nausea/vomiting subscore.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	4-Week Change in Nausea Symptom Severity	baseline and 4-weeks	All participants assigned to the arm with a 4-week visit and data for the nausea severity.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	4-Week Change in Vomiting Symptom Severity	baseline and 4-weeks	All participants assigned to the arm with a 4-week visit and data for vomiting severity.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	4-Week Change in Bloating and Stomach Distention Symptoms Severity	baseline and 4-weeks	All participants assigned to the arm with a 4-week visit data for the bloating subscore.	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 35Source ClinicalTrials.gov

See all 35 outcomes

Results by group98

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
4-Week Change in the Postprandial Fullness and Early Satiety Symptoms Severity	Buspirone	-1.16	Standard Deviation 1.25	score on a scale
4-Week Change in the Postprandial Fullness and Early Satiety Symptoms Severity	Placebo	-1.03	Standard Deviation 1.19	score on a scale
4-Week Change in Stomach Fullness Symptom Severity	Buspirone	-1.16	Standard Deviation 1.55	score on a scale
4-Week Change in Stomach Fullness Symptom Severity	Placebo	-1.07	Standard Deviation 1.34	score on a scale
4-Week Change in Excessive Fullness Symptom Severity	Buspirone	-1.14	Standard Deviation 1.56	score on a scale
4-Week Change in Excessive Fullness Symptom Severity	Placebo	-0.99	Standard Deviation 1.30	score on a scale
4-Week Change in Inability to Finish a Normal-sized Meal Symptom Severity	Buspirone	-1.27	Standard Deviation 1.55	score on a scale
4-Week Change in Inability to Finish a Normal-sized Meal Symptom Severity	Placebo	-1.12	Standard Deviation 1.63	score on a scale
4-Week Change in Loss of Appetite Symptom Severity	Buspirone	-1.09	Standard Deviation 1.64	score on a scale
4-Week Change in Loss of Appetite Symptom Severity	Placebo	-0.96	Standard Deviation 1.62	score on a scale

1 to 10 of 98Source ClinicalTrials.gov

See all 98 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Buspirone	47
Overall Study	STARTED	Placebo	49
Overall Study	COMPLETED	Buspirone	39
Overall Study	COMPLETED	Placebo	39
Overall Study	NOT COMPLETED	Buspirone	8
Overall Study	NOT COMPLETED	Placebo	10

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea, vomiting, retching	Gastrointestinal disorders	Buspirone	3	47	3
other	Nausea, vomiting, retching	Gastrointestinal disorders	Placebo	2	49	3
other	upper respiratory & sinus infection	Infections and infestations	Buspirone	3	47	3
other	upper respiratory & sinus infection	Infections and infestations	Placebo	1	49	1
other	QTC interval was high	Investigations	Buspirone	0	47	0
other	QTC interval was high	Investigations	Placebo	2	49	2
other	Worsening of a comorbid illness	Metabolism and nutrition disorders	Buspirone	1	47	1
other	Worsening of a comorbid illness	Metabolism and nutrition disorders	Placebo	0	49	0
other	Episodes of dizziness and somnolence	Nervous system disorders	Buspirone	3	47	3
other	Episodes of dizziness and somnolence	Nervous system disorders	Placebo	0	49	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Buspirone	0	47
Total, all-cause mortality	Placebo	0	49
Total, other adverse events	Buspirone	11	47
Total, other adverse events	Placebo	7	49
Total, serious adverse events	Buspirone	1	47
Total, serious adverse events	Placebo	1	49

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants7

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U01DK073974	Exploration of Subtypes of Gastroparesis and Gastroparesis-like Symptoms based on Physiological Testing	MOSHIREE, BAHARAK	WAKE FOREST UNIVERSITY HEALTH SCIENCES	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2006 to 2025	NIH RePORTER
U01DK073975	Temple University Gastroparesis Clinical Center	PARKMAN, HENRY PAUL	TEMPLE UNIV OF THE COMMONWEALTH	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2006 to 2025	NIH RePORTER
U01DK073983	Advancing Science for the Diagnosis and Treatment of Gastroparesis	PASRICHA, PANKAJ J	MAYO CLINIC ARIZONA	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2006 to 2025	NIH RePORTER
U01DK074007	U of L Clinical Center to Investigate the Pathogenesis, Etiology, and Treatment of Gastroparesis through the NIDDK Gastroparesis Consortium	ABELL, THOMAS LYMAN	UNIVERSITY OF LOUISVILLE	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2006 to 2025	NIH RePORTER
U01DK074035	A multicenter, double-blind, randomized, placebo- controlled, parallel study to assess the efficacy of 5- HT4 agonist prucalopride for the treatment of diabetic and idiopathic gastroparesis	SAROSIEK, IRENE	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2008 to 2025	NIH RePORTER
U01DK112193	New England Gastropareis Consortium: Neurobiology of Gastroparesis	BURTON MURRAY, HELEN; KUO, BRADEN	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2016 to 2025	NIH RePORTER
U24DK074008	Continuation of the Scientific Data Research Center (SDRC) of the Gastroparesis Clinical Research Consortium (GpCRC) 4	SHADE, DAVID M	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2017 to 2025	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Buspirone vs Placebo: deaths from any cause	Trial comparisons
Buspirone vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03587142

GET https://conductscience.org/api/trials/v1/NCT03587142/registered?page=2

API reference For AI assistants