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Buspirone for Early Satiety and Symptoms of Gastroparesis

NCT03587142 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-06-15

Study results available
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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

Interventions

DRUG

Buspirone

Buspirone tablet

DRUG

Placebo

"Sugar" pill manufactured to mimic buspirone 10 mg tablet

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Texas Tech University Health Sciences Center, El Paso

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Temple University

    collaborator OTHER

  • University of Louisville

    collaborator OTHER

  • Wake Forest University

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Henry P Parkman, MD · Temple University Hospital, Philadelphia, PA

  • Pankaj J Pasricha, MD · Johns Hopkins Hospital, Baltimore, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2022-04-15
Completion
2022-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03587142 on ClinicalTrials.gov