NCT03587142: BESST

Buspirone for Early Satiety and Symptoms of Gastroparesis

Completed Phase 2 Results posted Last updated 15 June 2023

What this trial tests

Phase 2 trial testing Buspirone in Gastroparesis in 96 participants. Completed in 30 April 2022.

Timeline

27 August 2019

Primary endpoint
15 April 2022

30 April 2022

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	96
Start date	27 August 2019
Primary completion	15 April 2022
Estimated completion	30 April 2022
Sites	6 locations across United States

Drugs / interventions tested

• Buspirone (BUSPIRONE) — full drug profile →
• Placebo

Conditions studied

• Gastroparesis — all drugs for Gastroparesis →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

Adults 18 to 85, any sex, with Gastroparesis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

4-Week Change in the Postprandial Fullness and Early Satiety Symptoms Severity Primary · 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.

Group	Value	95% CI
Buspirone	-1.16	± 1.25
Placebo	-1.03	± 1.19

4-Week Change in Stomach Fullness Symptom Severity Secondary · 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.

Group	Value	95% CI
Buspirone	-1.16	± 1.55
Placebo	-1.07	± 1.34

4-Week Change in Excessive Fullness Symptom Severity Secondary · 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.

Group	Value	95% CI
Buspirone	-1.14	± 1.56
Placebo	-0.99	± 1.30

4-Week Change in Inability to Finish a Normal-sized Meal Symptom Severity Secondary · 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.

Group	Value	95% CI
Buspirone	-1.27	± 1.55
Placebo	-1.12	± 1.63

4-Week Change in Loss of Appetite Symptom Severity Secondary · 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.

Group	Value	95% CI
Buspirone	-1.09	± 1.64
Placebo	-0.96	± 1.62

4-Week Change in Total Overall GCSI Symptom Severity Secondary · 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

Group	Value	95% CI
Buspirone	-1.06	± 1.16
Placebo	-0.86	± 1.00

4-Week Change in Nausea, Vomiting and Retching Symptoms Severity Secondary · 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.

Group	Value	95% CI
Buspirone	-0.65	± 1.40
Placebo	-0.60	± 1.26

4-Week Change in Nausea Symptom Severity Secondary · 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.

Group	Value	95% CI
Buspirone	-0.75	± 1.40
Placebo	-0.70	± 1.51

4-Week Change in Vomiting Symptom Severity Secondary · 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.

Group	Value	95% CI
Buspirone	-0.71	± 1.81
Placebo	-0.57	± 1.47

4-Week Change in Bloating and Stomach Distention Symptoms Severity Secondary · 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.

Group	Value	95% CI
Buspirone	-1.36	± 1.42
Placebo	-0.95	± 1.27

4-Week Change in Bloating Symptom Severity Secondary · baseline and 4-weeks

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.

Group	Value	95% CI
Buspirone	-1.34	± 1.46
Placebo	-0.69	± 1.18

4-Week Change in Upper Abdominal Pain and Discomfort Symptoms Severity Secondary · baseline and 4-weeks

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.

Group	Value	95% CI
Buspirone	-0.78	± 1.55
Placebo	-0.95	± 1.63

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were counted after randomization through end of treatment at 4-weeks.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Buspirone

Serious: 1/47 (2%)

Deaths: 0/47

Placebo

Serious: 1/49 (2%)

Deaths: 0/49

Serious adverse events (2 terms)

Reaction	System	Buspirone	Placebo
neurostimulator implantation	Surgical and medical procedures	—	—
severe allergic reaction	Immune system disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Buspirone	Placebo
Nausea, vomiting, retching	Gastrointestinal disorders	—	—
upper respiratory & sinus infection	Infections and infestations	—	—
Episodes of dizziness and somnolence	Nervous system disorders	—	—
QTC interval was high	Investigations	—	—
Worsening of a comorbid illness	Metabolism and nutrition disorders	—	—
urinary tract infection & renal calculi	Renal and urinary disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: neurostimulator implantation, severe allergic reaction.

Data from ClinicalTrials.gov NCT03587142 adverse events section.

Sponsor's own description

This study evaluates whether the study medication, buspirone, an antianxiety drug, improves the symptoms of gastroparesis in patients with gastroparesis symptoms and at least moderately severe symptoms of fullness and/or inability to eat a full meal. Half the patients will receive buspirone and half the patients will receive a placebo.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Treatment Options and Therapeutic Insights for Gastrointestinal Dysmotility and Functional Gastrointestinal Disorders.
   Singh R, Zogg H, Ghoshal UC, Ro S. · · 2022 · cited 67× · PMID 35145413 · DOI 10.3389/fphar.2022.808195
2. Buspirone for early satiety and symptoms of gastroparesis: A multi-centre, randomised, placebo-controlled, double-masked trial (BESST).
   Parkman HP, Yates KP, Sarosiek I, Bulat RS, et al · · 2023 · cited 22× · PMID 37052334 · DOI 10.1111/apt.17479