Buspirone for Early Satiety and Symptoms of Gastroparesis

NCT03587142 | Completed Phase 2 Results DMC FDA Drug

• 8 other identifiers: 10- GpCRC3-BESSTU01DK073983U01DK112193U01DK073975U01DK074035U01DK074007U01DK073974U24DK074008
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 6

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.

Conditions

Gastroparesis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 4-weeks

Secondary Outcomes (24)

• 4-Week Change in Stomach Fullness Symptom Severity

  baseline and 4-weeks

• 4-Week Change in Excessive Fullness Symptom Severity

  baseline and 4-weeks

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

  baseline and 4-weeks

• 4-Week Change in Loss of Appetite Symptom Severity

  baseline and 4-weeks

• 4-Week Change in Total Overall GCSI Symptom Severity

  baseline and 4-weeks

Other Outcomes (10)

• 4-Week Change in Weight

  baseline and 4-weeks

• 4-Week Cardiac Rhythm

  baseline and 4-weeks

• 4-Week Change in Aspartate Aminotransferase (ALT)

  baseline and 4-weeks

Study Arms (2)

Buspirone

ACTIVE COMPARATOR

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

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

Drug: Placebo

Interventions

Buspirone DRUG

Buspirone tablet

Also known as: Buspar, buspirone hydrochloride (HCl), Buspar Dividose, Vanspar

Buspirone

Placebo DRUG

"Sugar" pill manufactured to mimic buspirone 10 mg tablet

Also known as: Placebo (for buspirone)

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Texas Tech University Health Sciences Center, El Paso: collaborator
• Johns Hopkins University: collaborator
• Temple University: collaborator
• University of Louisville: collaborator
• Wake Forest University: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (6)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Texas Tech University Health Science Center

El Paso, Texas, 79905, United States

Location

Related Links

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

MeSH Terms

Conditions

Gastroparesis

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Henry Parkman
• Organization: Temple University

henry.parkman@temple.edu

(215) 707-7579

Study Officials

• Henry P Parkman, MD

  Temple University Hospital, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

• Pankaj J Pasricha, MD

  Johns Hopkins Hospital, Baltimore, MD

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 16, 2018
• Study Start: August 27, 2019
• Primary Completion: April 15, 2022
• Study Completion: April 30, 2022
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

US (6)