CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 26 enrolled
Drug / intervention
Onabotulinumtoxin A (BoNT) +4 moredrug
Likely dose
belladonna 16.2mgfrom 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/NCT02600715
NCT02600715Phase 4Completed
CompareCT.gov

Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)

Edgar LeClaire, MD·interventional·Posted Nov 9, 2015·Updated Sep 20, 2018

In Brief

A Phase 4 clinical trial evaluating Onabotulinumtoxin A (BoNT), belladonna, and 3 other interventions for Overactive Bladder and 3 related conditions. Completed, enrolled 26 participants across 2 sites.

Detailed Summary

The purpose of this study is to test whether using belladonna \& opiate suppositories (B\&Os) can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial cystitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder, Urinary Urge Incontinence, Urinary Bladder, Neurogenic, Painful Bladder Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 9, 2015
Enrollment StartNov 1, 2015
Primary CompletionJun 26, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.6 years ago

Interventions

Onabotulinumtoxin A (BoNT)drug

belladonnadrug

Part of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg.

Morphinedrug

Part of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg.

Placebodrug

matching placebo to B\&O suppository

Active B&O suppository of belladonnadrug

belladonna 16.2mg and morphine 7.5mg