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Buspirone for Early Satiety and Symptoms of Gastroparesis (BESST)

Primary Purpose

Gastroparesis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Buspirone

Placebo

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring gastroparesis, early satiety, stomach, buspirone, 5-HT 1a receptor agonist

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

University of Louisville
Johns Hopkins Hospital
Massachusetts General Hospital
Wake Forest University Health Sciences
Temple University
Texas Tech University Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Buspirone

Placebo

Arm Description

Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks

Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

Full Information

NCT ID

NCT03587142

First Posted

July 2, 2018

Last Updated

June 14, 2023

Sponsor

Johns Hopkins Bloomberg School of Public Health

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

1. Study Identification

Unique Protocol Identification Number

NCT03587142

Brief Title

Buspirone for Early Satiety and Symptoms of Gastroparesis

Acronym

BESST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 27, 2019 (Actual)

Primary Completion Date

April 15, 2022 (Actual)

Study Completion Date

April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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. Half the patients will receive buspirone and half the patients will receive a placebo.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroparesis

Keywords

gastroparesis, early satiety, stomach, buspirone, 5-HT 1a receptor agonist

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigator

Masking Description

Participants, all clinic staff and the investigators will be masked as to whether the participant is receiving buspirone or the placebo. The study drug will be over encapsulated in a size 0 gelatin capsule with partial filler to be identical to the placebo capsule, which contains only filler. The random treatment assignment will consist of a numbered study drug bottle; each bottle number will be unique and each participant will be assigned a specific bottle number, which is labelled: "Buspirone or placebo 10 mg." with directions. The randomization scheme will assign participants in randomly permuted blocks of assignments stratified by clinical center. The randomization plan will be prepared and administered centrally via a secure web application by the Scientific Data Research Center.

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Buspirone

Arm Type

Active Comparator

Arm Description

Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule

Intervention Type

Drug

Intervention Name(s)

Buspirone

Other Intervention Name(s)

Buspar, buspirone hydrochloride (HCl), Buspar Dividose, Vanspar

Intervention Description

Buspirone tablet

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo (for buspirone)

Intervention Description

"Sugar" pill manufactured to mimic buspirone 10 mg tablet

Primary Outcome Measure Information:

Title

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

Description

Time Frame

baseline and 4-weeks

Secondary Outcome Measure Information:

Title

4-Week Change in Stomach Fullness Symptom Severity

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Excessive Fullness Symptom Severity

Description

Time Frame

baseline and 4-weeks

Title

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

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Loss of Appetite Symptom Severity

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Total Overall GCSI Symptom Severity

Description

Time Frame

baseline and 4-weeks

Title

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

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Nausea Symptom Severity

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Vomiting Symptom Severity

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Bloating and Stomach Distention Symptoms Severity

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Bloating Symptom Severity

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Upper Abdominal Pain and Discomfort Symptoms Severity

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Upper Abdominal Pain Symptom Severity

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Gastroesophageal (GERD) Symptoms Severity

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Gastrointestinal Symptoms Rating Scale (GSRS) Global Score

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Participant's Rating of Symptom Relief

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Severity of Somatic Symptoms

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Depression

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Anxiety

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change Overall Quality of Health Due to Gastroparesis Issues

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Overall Mental Quality of Life (QOL)

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Overall Physical Quality of Life (QOL)

Description

Time Frame

baseline and 4-weeks

Title

4-Week Change in Gastric Retention

Description

Time Frame

baseline and 4-weeks

Title

Change at 4-weeks in the Intragastric Meal Distribution (IMD)

Description

Time Frame

baseline and 4-weeks

Title

Change From Baseline at 4-weeks in the Water Load Satiety Test (WLST)

Description

Time Frame

baseline and 4-weeks

Other Pre-specified Outcome Measures:

Title

4-Week Change in Weight

Description

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

Time Frame

baseline and 4-weeks

Title

4-Week Cardiac Rhythm

Description

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

Time Frame

baseline and 4-weeks

Title

4-Week Change in Aspartate Aminotransferase (ALT)

Description

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

Time Frame

baseline and 4-weeks

Title

4-Week Change in Creatinine

Description

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

Time Frame

baseline and 4-weeks

Title

4-Week Change in Fasting Glucose

Description

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

Time Frame

baseline and 4-weeks

Title

Assessment of Adverse Events Over 4-Weeks

Description

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.

Time Frame

over 4-weeks

Title

Assessment of the Severity of Adverse Events Over 4-Weeks

Description

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.

Time Frame

over 4-weeks

Title

Serious Adverse Events

Description

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.

Time Frame

over 4 weeks of treatment

Title

Total Number of Hospitalizations Over 4-weeks of Treatment

Description

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.

Time Frame

over the 4-weeks of the trial

Title

Adverse Events by Body Classification System by Treatment Group During the Trial

Description

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

Time Frame

over 4-weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry P Parkman, MD

Organizational Affiliation

Temple University Hospital, Philadelphia, PA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pankaj J Pasricha, MD

Organizational Affiliation

Johns Hopkins Hospital, Baltimore, MD

Official's Role

Study Chair

Facility Information:

Facility Name

University of Louisville

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Temple University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Texas Tech University Health Science Center

City

El Paso

State/Province

Texas

ZIP/Postal Code

79905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

The analytic datasets to produce the primary result manuscript will be submitted within one year of publication of the primary result manuscript. The full clinical dataset for all Clinical Study Reports (CSRs) without proprietary restrictions will be submitted within 2 years of the primary result manuscript publication. This data will be available publicly indefinitely.

IPD Sharing Access Criteria

An investigator interested in acquiring BESST study data should contact the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository at https://www.niddkrepository.org/search/study/ and apply to obtain the data required for their study.

IPD Sharing URL

https://repository.niddk.nih.gov/home/

Links:

URL

https://jhuccs1.us/gpcrc/default.asp

Description

Link to the Gastroparesis Clinical Research Consortium (GpCRC) web site Home page. There are some open-links for patients, such as Information for Patients.

Learn more about this trial

Buspirone for Early Satiety and Symptoms of Gastroparesis

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