A Phase 2 interventional study of Buspirone and Placebo in Gastroparesis, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 6 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 2, Interventional, and Treatment
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.
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.
307 studies on the registry are indexed under Gastroparesis; 67 are open to participants now.
This study's enrollment of 96 is above the median of 44 across 201 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
Buspirone HCl 10 mg capsule orally three times daily, 30 minutes before each meal, for 4-weeks
Drug: Buspirone
Placebo capsule orally three times daily, 30 minutes before each meal, for 4-weeks; manufactured to look identical to buspirone capsule
Drug: Placebo
Buspirone tablet
Also known as: Buspar, buspirone hydrochloride (HCl), Buspar Dividose, Vanspar
"Sugar" pill manufactured to mimic buspirone 10 mg tablet
Also known as: Placebo (for buspirone)
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.
Time frame: baseline and 4-weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: baseline and 4-weeks
4-Week Change in Weight
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
4-Week Cardiac Rhythm
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
4-Week Change in Aspartate Aminotransferase (ALT)
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
4-Week Change in Creatinine
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
4-Week Change in Fasting Glucose
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
Assessment of Adverse Events 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.
Time frame: over 4-weeks
Assessment of the Severity of Adverse Events Over 4-Weeks
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
Serious Adverse Events
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
Total Number of Hospitalizations Over 4-weeks of Treatment
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
Adverse Events by Body Classification System by Treatment Group During the Trial
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
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.
| Milestone | Buspirone | Placebo |
|---|---|---|
| Started | 47 | 49 |
| Completed | 39 | 39 |
| Not completed | 8 | 10 |
| Withdrew: Lost to follow-up | 5 | 3 |
| Withdrew: Did not complete the f4 visit | 3 | 7 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in the Postprandial Fullness and Early Satiety Symptoms Severity | -1.16 ± 1.25 | -1.03 ± 1.19 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Stomach Fullness Symptom Severity | -1.16 ± 1.55 | -1.07 ± 1.34 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Excessive Fullness Symptom Severity | -1.14 ± 1.56 | -0.99 ± 1.30 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Inability to Finish a Normal-sized Meal Symptom Severity | -1.27 ± 1.55 | -1.12 ± 1.63 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Loss of Appetite Symptom Severity | -1.09 ± 1.64 | -0.96 ± 1.62 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Total Overall GCSI Symptom Severity | -1.06 ± 1.16 | -0.86 ± 1.00 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Nausea, Vomiting and Retching Symptoms Severity | -0.65 ± 1.40 | -0.60 ± 1.26 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Nausea Symptom Severity | -0.75 ± 1.40 | -0.70 ± 1.51 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Vomiting Symptom Severity | -0.71 ± 1.81 | -0.57 ± 1.47 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Bloating and Stomach Distention Symptoms Severity | -1.36 ± 1.42 | -0.95 ± 1.27 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Bloating Symptom Severity | -1.34 ± 1.46 | -0.69 ± 1.18 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Upper Abdominal Pain and Discomfort Symptoms Severity | -0.78 ± 1.55 | -0.95 ± 1.63 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Upper Abdominal Pain Symptom Severity | -0.69 ± 1.73 | -0.93 ± 1.63 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Gastroesophageal (GERD) Symptoms Severity | -0.36 ± 1.44 | -0.45 ± 1.01 |
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.
| units on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Gastrointestinal Symptoms Rating Scale (GSRS) Global Score | -0.63 ± 1.09 | -0.49 ± 0.90 |
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.
| units on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Participant's Rating of Symptom Relief | 0.69 ± 1.03 | 0.37 ± 1.10 |
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.
| units on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Severity of Somatic Symptoms | -0.99 ± 3.88 | -2.00 ± 3.93 |
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.
| units on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Depression | 0.42 ± 4.06 | -1.43 ± 3.91 |
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.
| units on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Anxiety | -1.27 ± 4.82 | -2.03 ± 3.94 |
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.
| score on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change Overall Quality of Health Due to Gastroparesis Issues | 0.43 ± 0.81 | 0.64 ± 0.95 |
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.
| units on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Overall Mental Quality of Life (QOL) | 1.19 ± 10.54 | 3.17 ± 11.83 |
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.
| units on a scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Overall Physical Quality of Life (QOL) | 1.10 ± 7.18 | 3.17 ± 5.95 |
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).
| units on a percentage scale | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Gastric Retention | 4.24 ± 21.19 | 2.87 ± 21.8 |
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.
| ratio | Buspirone | Placebo |
|---|---|---|
| Change at 4-weeks in the Intragastric Meal Distribution (IMD) | -0.04 ± 0.13 | 0.02 ± 0.13 |
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.
| ml | Buspirone | Placebo |
|---|---|---|
| Change From Baseline at 4-weeks in the Water Load Satiety Test (WLST) | -43.3 ± 219.1 | -21.8 ± 145.6 |
This safety outcome is computed by subtracting the weight (kg) at baseline from the weight (kg) at 4-weeks
| kilogram | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Weight | -0.34 ± 1.36 | -0.43 ± 1.99 |
This safety outcome is computed from the results of an electrocardiogram (ECG) QTc interval at 4-weeks measured in milliseconds (msec).
| milliseconds (msec) | Buspirone | Placebo |
|---|---|---|
| 4-Week Cardiac Rhythm | -2.80 ± 19.18 | 3.63 ± 23.42 |
This safety outcome is computed by subtracting the baseline level of Alanine Aminotransferase (ALT) (U/L) from the 4-week level.
| U/L | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Aspartate Aminotransferase (ALT) | 0.32 ± 15.93 | 1.34 ± 9.57 |
This safety outcome is computed by subtracting the baseline level of creatinine (mg/dL) from the 4-week level.
| mg/dL | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Creatinine | 0.02 ± 0.07 | -0.01 ± 0.11 |
This safety outcome is computed by subtracting the baseline level of glucose (mg/dL) from the 4-week level.
| mg/dL | Buspirone | Placebo |
|---|---|---|
| 4-Week Change in Fasting Glucose | 10.30 ± 38.10 | 10.69 ± 42.21 |
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.
| events | Buspirone | Placebo |
|---|---|---|
| Assessment of Adverse Events Over 4-Weeks | 12 | 8 |
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.
| Participants | Buspirone | Placebo |
|---|---|---|
| No Adverse events | 35 | 41 |
| 1-mild severity | 5 | 2 |
| 2-moderate severity | 6 | 6 |
| 3-severe | 1 | 0 |
| 4-life threatening | 0 | 0 |
| 5-death | 0 | 0 |
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.
| Serious adverse events | Buspirone | Placebo |
|---|---|---|
| Serious Adverse Events | 1 | 1 |
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.
| hospitalizations | Buspirone | Placebo |
|---|---|---|
| Total Number of Hospitalizations Over 4-weeks of Treatment | 1 | 0 |
Adverse events were reported on the Adverse Event Report form by the principal investigator at each clinic site using the CTCAE v5 classification system.
| events by body classification | Buspirone | Placebo |
|---|---|---|
| Gastrointestinal | 3 | 3 |
| Immune system | 1 | 0 |
| Infections & infestations | 3 | 1 |
| Investigations | 0 | 2 |
| Metabolic & nutrition | 1 | 0 |
| Nervous system | 3 | 0 |
| Renal & urinary | 1 | 1 |
| Surgical & medical | 0 | 1 |
| Musculoskeletal & connective tissue disorders | 0 | 1 |
| Total | 12 | 9 |
Collected over Adverse events were counted after randomization through end of treatment at 4-weeks.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Buspirone | 0/47 (0%) | 1/47 (2.1%) | 11/47 (23.4%) |
| Placebo | 0/49 (0%) | 1/49 (2%) | 7/49 (14.3%) |
| Event | Buspirone | Placebo |
|---|---|---|
| severe allergic reactionImmune system disorders | 1/47 | 0/49 |
| neurostimulator implantationSurgical and medical procedures | 0/47 | 1/49 |
| Event | Buspirone | Placebo |
|---|---|---|
| Nausea, vomiting, retchingGastrointestinal disorders | 3/47 | 2/49 |
| upper respiratory & sinus infectionInfections and infestations | 3/47 | 1/49 |
| Episodes of dizziness and somnolenceNervous system disorders | 3/47 | 0/49 |
| QTC interval was highInvestigations | 0/47 | 2/49 |
| Worsening of a comorbid illnessMetabolism and nutrition disorders | 1/47 | 0/49 |
| urinary tract infection & renal calculiRenal and urinary disorders | 1/47 | 1/49 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/47 | 1/49 |
| Age, Continuous(years) | Buspirone | Placebo | Total |
|---|---|---|---|
| Mean | 43.0 ± 15.8 | 44.2 ± 15.0 | 43.6 ± 15.3 |
| Sex: Female, Male(Participants) | Buspirone | Placebo | Total |
|---|---|---|---|
| Female | 43 | 45 | 88 |
| Male | 4 | 4 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Buspirone | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 17 | 30 |
| Not Hispanic or Latino | 34 | 32 | 66 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Buspirone | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 2 | 5 | 7 |
| White | 43 | 41 | 84 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Married(Participants) | Buspirone | Placebo | Total |
|---|---|---|---|
| Count of participants | 16 | 21 | 37 |
| Diabetes Type 1(Participants) | Buspirone | Placebo | Total |
|---|---|---|---|
| Count of participants | 3 | 6 | 9 |
| Diabetes Type 2(Participants) | Buspirone | Placebo | Total |
|---|---|---|---|
| Count of participants | 13 | 15 | 28 |
| Body Mass Index (BMI)(kg/m^2) | Buspirone | Placebo | Total |
|---|---|---|---|
| Mean | 29.5 ± 7.5 | 29.8 ± 7.3 | 29.7 ± 7.4 |
35 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Johns Hopkins Bloomberg School of Public Health