Buspirone for Early Satiety and Symptoms of Gastroparesis



Status:Not yet recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/15/2019
Start Date:March 31, 2019
End Date:June 2020
Contact:SDRC Principal Investigator James /Tonascia, PhD
Email:jtonasc1@jhu.edu
Phone:410-955-3704

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

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.

Inclusion Criteria:

- Age 18 to 75 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
We found this trial at
6
sites
415 East Yandell Drive
El Paso, Texas 79905
Principal Investigator: Richard W McCallum, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Braden Kuo, MD
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Pankaj J Pasricha, MD
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Thomas Abell, MD
University of Louisville The University of Louisville is a state supported research university located in...
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Henry P Parkman, MD
Temple University Temple University is many things to many people. A place to pursue life's...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Kenneth Koch, MD
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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