CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
Buspirone +1 moredrug
Likely dose
Placebo 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03587142
NCT03587142Phase 2Completed
CompareCT.gov

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

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Jul 16, 2018·Updated Jun 15, 2023

In Brief

A Phase 2 clinical trial evaluating Buspirone and Placebo for Gastroparesis. Completed, enrolled 96 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroparesis
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Texas Tech University Health Sciences Center, El Paso, Johns Hopkins University, Temple University, University of Louisville, Wake Forest University, Massachusetts General Hospital

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 16, 2018
Enrollment StartAug 27, 2019
Primary CompletionApr 15, 2022
Study CompletionApr 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.0 years ago

Interventions

Buspironedrug

Buspirone tablet

Placebodrug

"Sugar" pill manufactured to mimic buspirone 10 mg tablet