GastroparesisPhase 2BESSTNCT03587142

Buspirone for Early Satiety and Symptoms of Gastroparesis

A Phase 2 study testing Buspirone in people with Gastroparesis, run by Johns Hopkins Bloomberg School of Public Health at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Gastroparesis
What is being tested?: Buspirone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 6 sitesUnited States
Study dates: 27 Aug 2019to 30 Apr 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 to 85 years of age at initial screening interview
Symptoms compatible with gastroparesis or other functional gastric disorder for at least 3 months (does not have to be contiguous) prior to initial screening interview
Diagnosis of either diabetic or idiopathic gastroparesis
Delayed or normal gastric emptying retention on screening 4-hour Gastric Emptying Scintigraphy test
Symptoms of gastroparesis measured by the 9-item PAGI-SYM Gastroparesis Cardinal Symptom Index (GCSI) total score > 2.0 at enrollment
Symptomatic with postprandial fullness/early satiety severity at enrollment using the PAGI-SYM GCSI post-prandial fullness/early satiety subscore ≥ 3
Upper endoscopy or upper GI series without ulcers or mass lesions in the 2 years prior to enrollment

Who cannot join

Post-surgical gastroparesis, including prior pyloromyotomy, pyloric resection, vagotomy, bariatric surgery or post-Nissen fundoplication
Another active disorder which could explain symptoms in the opinion of the investigator
Concurrent use of opiate narcotic analgesics more than 3 days per week
Significant hepatic injury as defined by alanine aminotransferase (ALT) elevation of greater than twice the Upper Limit of Normal (ULN) or a Child-Pugh score of 10 or greater
Significant renal impairment as defined by serum creatinine > 3.0
Uncontrolled diabetes defined as HbA1c (%) of 10% or more within 60 days of enrollment

Show all 13Show fewer

Allergy to buspirone
Concurrent or prior use (within 30 days) of monoamine oxidase (MAO) inhibitors
Concurrent or prior use (within 30 days) of benzodiazepines
Concurrent or prior use (within 30 days) of buspirone, warfarin, haloperidol, and drugs to treat seizures (e.g., phenytoin and carbamazepine)
Women breast feeding or known to be pregnant
Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
Failure to give informed consent

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Texas Tech University Health Science Center
El Paso, Texas, 79905
University of Louisville
Louisville, Kentucky, 40202
Temple University
Philadelphia, Pennsylvania, 19140
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Buspirone for Early Satiety and Symptoms of Gastroparesis: A Multicenter, Randomized, Placebo-Controlled, Double-Masked Trial (BESST)

Read the detailed description

This is a multi-center, randomized, double-masked, placebo-controlled, parallel treatment groups phase 2 trial to determine the effect of buspirone, a 5-hydroxytryptamine (5-HT) 1a receptor agonist, on early satiety and postprandial fullness in participants with symptoms of gastroparesis and with at least moderately severe symptoms of early satiety and/or postprandial fullness. After enrollment, participants aged 18-75 years will be treated with buspirone (10 mg three times per day) or a matching placebo for 4 weeks, followed by a 2-week post-treatment washout period. The primary outcome for the study is 4-week change (week 4 minus baseline) in the 4-item postprandial fullness/early satiety subscore (higher scores indicate worse symptoms) from the Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) Gastroparesis Cardinal Symptom Index (GCSI). We hypothesize that buspirone treatment will improve symptoms of postprandial fullness/early satiety compared to treatment with placebo, as indicated by a lower (smaller, more negative) 4-week change in the postprandial fullness/early satiety subscore in the buspirone arm compared to the placebo arm; change for a participant will be calculated as subscore at 4-weeks minus subscore at baseline.

Conditions: Gastroparesis
Being tested: Buspirone, Placebo
Keywords: gastroparesis, early satiety, stomach, buspirone, 5-HT 1a receptor agonist
Medical subject headings: Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BuspironeDrug
Also called Buspar, buspirone hydrochloride (HCl), Buspar Dividose, Vanspar
Buspirone tablet
PlaceboDrug
Also called Placebo (for buspirone)
"Sugar" pill manufactured to mimic buspirone 10 mg tablet

Study groups in NCT03587142
Study group	Role	What they receive
Buspirone	Active comparator	Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks Receives: Drug: Buspirone
Placebo	Placebo comparator	Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

4-Week Change in the Postprandial Fullness and Early Satiety Symptoms Severity
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.
Measured: baseline and 4-weeks

Secondary outcomes (24)

4-Week Change in Stomach Fullness Symptom Severity
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.
Measured: baseline and 4-weeks
4-Week Change in Excessive Fullness Symptom 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.
Measured: baseline and 4-weeks
4-Week Change in Inability to Finish a Normal-sized Meal Symptom Severity
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.
Measured: baseline and 4-weeks
4-Week Change in Loss of Appetite Symptom 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.
Measured: baseline and 4-weeks
4-Week Change in Total Overall GCSI Symptom Severity
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.
Measured: baseline and 4-weeks
4-Week Change in Nausea, Vomiting and Retching Symptoms Severity
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.
Measured: baseline and 4-weeks
4-Week Change in Nausea Symptom 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.
Measured: baseline and 4-weeks
4-Week Change in Vomiting Symptom 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.
Measured: baseline and 4-weeks
4-Week Change in Bloating and Stomach Distention Symptoms Severity
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.
Measured: baseline and 4-weeks
4-Week Change in Bloating Symptom 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.
Measured: baseline and 4-weeks
4-Week Change in Upper Abdominal Pain and Discomfort Symptoms Severity
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.
Measured: baseline and 4-weeks
4-Week Change in Upper Abdominal Pain Symptom Severity
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.
Measured: baseline and 4-weeks
4-Week Change in Gastroesophageal (GERD) Symptoms Severity
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.
Measured: baseline and 4-weeks
4-Week Change in Gastrointestinal Symptoms Rating Scale (GSRS) Global 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.
Measured: baseline and 4-weeks
4-Week Change in Participant's Rating of Symptom Relief
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.
Measured: baseline and 4-weeks
4-Week Change in Severity of Somatic Symptoms
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.
Measured: baseline and 4-weeks
4-Week Change in Depression
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.
Measured: baseline and 4-weeks
4-Week Change in Anxiety
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.
Measured: baseline and 4-weeks
4-Week Change Overall Quality of Health Due to Gastroparesis Issues
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.
Measured: baseline and 4-weeks
4-Week Change in Overall Mental Quality of Life (QOL)
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.
Measured: baseline and 4-weeks
4-Week Change in Overall Physical Quality of Life (QOL)
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.
Measured: baseline and 4-weeks
4-Week Change in Gastric Retention
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).
Measured: baseline and 4-weeks
Change at 4-weeks in the Intragastric Meal Distribution (IMD)
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.
Measured: baseline and 4-weeks
Change From Baseline at 4-weeks in the Water Load Satiety Test (WLST)
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.
Measured: baseline and 4-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 201930 Apr 2022

First posted16 Jul 2018
Study start27 Aug 2019
Primary completion15 Apr 2022
Study completion30 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GastroparesisStudies of the same condition, open and under way.
More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: BESST is a multi-center, randomized, placebo-controlled, double-masked, parallel treatment groups phase 2 trial with half the participants receiving the study drug, buspirone, and half receiving the placebo.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03587142
Sponsor's protocol ID: 10- GpCRC3-BESST
Other IDs: U01DK073983, U01DK112193, U01DK073975, U01DK074035, U01DK074007, U01DK073974, U24DK074008
Acronym: BESST
Status last verified: Jun 2023
First submitted: 2 Jul 2018
Last updated: 15 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The study will comply with the NIH Data Sharing Policy. The data will be first de-identified so that no individual participant identifiers will be included in the dataset (no names, addresses, dates, comments, etc). If a characteristic is an extreme value for this population, then those values will be categorized into one frequency group. If a CSR has multiple versions, then all data will be recoded into the format of the most current form version. A random unique identification number will be substituted for the unique BESST identification number. If a clinical item was obtained from surveys with restrictions due to licensing, then that data will be excluded. The data will be shared in 2 stages: the first will be the analytic datasets to produce the primary outcome paper. For this dataset, the documentation will include analytic code. The full dataset by CSR will be provided in the second stage.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
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Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
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All Gastroparesis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Buspirone for Early Satiety and Symptoms of Gastroparesis: A Multicenter, Randomized, Placebo-Controlled, Double-Masked Trial (BESST)
ClinicalTrials.gov ID: NCT03587142
Acronym / sponsor ID: BESST / 10- GpCRC3-BESST
Conditions: Gastroparesis
Keywords: gastroparesis, early satiety, stomach, buspirone, 5-HT 1a receptor agonist
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Texas Tech University Health Sciences Center, El Paso, Johns Hopkins University, Temple University, University of Louisville, Wake Forest University, Massachusetts General Hospital
Study start: 27 Aug 2019 (actual)
Primary completion: 15 Apr 2022 (actual)
Study completion: 30 Apr 2022 (actual)
First posted: 16 Jul 2018 (actual)
Results: Posted 15 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: BESST is a multi-center, randomized, placebo-controlled, double-masked, parallel treatment groups phase 2 trial with half the participants receiving the study drug, buspirone, and half receiving the placebo.

Arm	Type	Receives
Buspirone	Active comparator	Drug: BuspironeBuspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 18 to 85 years of age at initial screening interview
Symptoms compatible with gastroparesis or other functional gastric disorder for at least 3 months (does not have to be contiguous) prior to initial screening interview
Diagnosis of either diabetic or idiopathic gastroparesis
Delayed or normal gastric emptying retention on screening 4-hour Gastric Emptying Scintigraphy test
Symptoms of gastroparesis measured by the 9-item PAGI-SYM Gastroparesis Cardinal Symptom Index (GCSI) total score > 2.0 at enrollment

Key exclusion criteria (13 listed)

Post-surgical gastroparesis, including prior pyloromyotomy, pyloric resection, vagotomy, bariatric surgery or post-Nissen fundoplication
Another active disorder which could explain symptoms in the opinion of the investigator
Concurrent use of opiate narcotic analgesics more than 3 days per week
Significant hepatic injury as defined by alanine aminotransferase (ALT) elevation of greater than twice the Upper Limit of Normal (ULN) or a Child-Pugh score of 10 or greater
Significant renal impairment as defined by serum creatinine > 3.0

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BuspironeAlso: Buspar, buspirone hydrochloride (HCl), Buspar Dividose, VansparBuspirone tablet	Drug	Buspirone
PlaceboAlso: Placebo (for buspirone)"Sugar" pill manufactured to mimic buspirone 10 mg tablet	Drug	Placebo

Primary outcome

4-Week Change in the Postprandial Fullness and Early Satiety Symptoms Severity
Time frame: 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.

24 secondary outcomes

4-Week Change in Stomach Fullness Symptom Severity
Time frame: baseline and 4-weeks
4-Week Change in Excessive Fullness Symptom Severity
Time frame: baseline and 4-weeks
4-Week Change in Inability to Finish a Normal-sized Meal Symptom Severity
Time frame: baseline and 4-weeks
4-Week Change in Loss of Appetite Symptom Severity
Time frame: baseline and 4-weeks
4-Week Change in Total Overall GCSI Symptom Severity
Time frame: baseline and 4-weeks
4-Week Change in Nausea, Vomiting and Retching Symptoms Severity
Time frame: baseline and 4-weeks
4-Week Change in Nausea Symptom Severity
Time frame: baseline and 4-weeks
4-Week Change in Vomiting Symptom Severity
Time frame: baseline and 4-weeks
4-Week Change in Bloating and Stomach Distention Symptoms Severity
Time frame: baseline and 4-weeks
4-Week Change in Bloating Symptom Severity
Time frame: baseline and 4-weeks
4-Week Change in Upper Abdominal Pain and Discomfort Symptoms Severity
Time frame: baseline and 4-weeks
4-Week Change in Upper Abdominal Pain Symptom Severity
Time frame: baseline and 4-weeks
4-Week Change in Gastroesophageal (GERD) Symptoms Severity
Time frame: baseline and 4-weeks
4-Week Change in Gastrointestinal Symptoms Rating Scale (GSRS) Global Score
Time frame: baseline and 4-weeks
4-Week Change in Participant's Rating of Symptom Relief
Time frame: baseline and 4-weeks
4-Week Change in Severity of Somatic Symptoms
Time frame: baseline and 4-weeks
4-Week Change in Depression
Time frame: baseline and 4-weeks
4-Week Change in Anxiety
Time frame: baseline and 4-weeks
4-Week Change Overall Quality of Health Due to Gastroparesis Issues
Time frame: baseline and 4-weeks
4-Week Change in Overall Mental Quality of Life (QOL)
Time frame: baseline and 4-weeks
4-Week Change in Overall Physical Quality of Life (QOL)
Time frame: baseline and 4-weeks
4-Week Change in Gastric Retention
Time frame: baseline and 4-weeks
Change at 4-weeks in the Intragastric Meal Distribution (IMD)
Time frame: baseline and 4-weeks
Change From Baseline at 4-weeks in the Water Load Satiety Test (WLST)
Time frame: baseline and 4-weeks

Results and safety

Results posted to the registry on 15 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Buspirone	47	39
Placebo	49	39

Primary outcome: 4-Week Change in the Postprandial Fullness and Early Satiety Symptoms Severity

Time frame: baseline and 4-weeks. Least squares mean (Standard Deviation). Unit: score on a scale

Measure	Buspirone n = 47	Placebo n = 49
Value	-1.16 (1.25)	-1.03 (1.19)

Buspirone vs Placebo: Mean Difference (Net): -0.11 (95% CI -0.68 to 0.45), p = 0.69, ANCOVA
Buspirone vs Placebo: Mean Difference (Net): -0.13 (95% CI -0.65 to 0.39), p = 0.62, ANCOVA
Buspirone vs Placebo: Mean Difference (Net): -0.25 (95% CI -0.89 to 0.38), p = 0.62, ANCOVA

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

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were counted after randomization through end of treatment at 4-weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Buspirone	1 of 47 (2.1%)	11 of 47 (23.4%)	0 of 47
Placebo	1 of 49 (2%)	7 of 49 (14.3%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Link to the Gastroparesis Clinical Research Consortium (GpCRC) web site Home page. There are some open-links for patients, such as Information for Patients.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. The study will comply with the NIH Data Sharing Policy. The data will be first de-identified so that no individual participant identifiers will be included in the dataset (no names, addresses, dates, comments, etc). If a characteristic is an extreme value for this population, then those values will be categorized into one frequency group. If a CSR has multiple versions, then all data will be recoded into the format of the most current form version. A random unique identification number will be substituted for the unique BESST identification number. If a clinical item was obtained from surveys with restrictions due to licensing, then that data will be excluded. The data will be shared in 2 stages: the first will be the analytic datasets to produce the primary outcome paper. For this dataset, the documentation will include analytic code. The full dataset by CSR will be provided in the second stage.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Henry P Parkman, MD principal investigator

Temple University Hospital, Philadelphia, PA

Pankaj J Pasricha, MD study chair

Johns Hopkins Hospital, Baltimore, MD

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Buspirone in people with Gastroparesis, run by Johns Hopkins Bloomberg School of Public Health at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

4-Week Change in the Postprandial Fullness and Early Satiety Symptoms Severity (time frame: baseline and 4-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03587142.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.