Buspirone for Early Satiety and Symptoms of Gastroparesis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-27

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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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

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Gastroparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Buspirone

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

Group Type ACTIVE_COMPARATOR

Buspirone

Intervention Type DRUG

Buspirone tablet

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

"Sugar" pill manufactured to mimic buspirone 10 mg tablet

Interventions

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Buspirone

Buspirone tablet

Intervention Type DRUG

Placebo

"Sugar" pill manufactured to mimic buspirone 10 mg tablet

Intervention Type DRUG

Other Intervention Names

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Buspar buspirone hydrochloride (HCl) Buspar Dividose Vanspar Placebo (for buspirone)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henry P Parkman, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University Hospital, Philadelphia, PA

Pankaj J Pasricha, MD

Role: STUDY_CHAIR

Johns Hopkins Hospital, Baltimore, MD

Locations

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University of Louisville

Louisville, Kentucky, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

Texas Tech University Health Science Center

El Paso, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document