CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Botulinum toxin A +1 moredrug
Likely dose
Not stated in 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/NCT00372970
NCT00372970N/ACompleted
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Randomized Placebo-Controlled Double Blind Study of Botulinum Toxin Versus Placebo for the Treatment of Gastroparesis

Temple University·interventional·Posted Sep 7, 2006·Updated Jun 9, 2015

In Brief

A clinical study evaluating Botulinum toxin A and Placebo for Gastroparesis. Completed, enrolled 32 participants across 1 site.

Detailed Summary

It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a contributing feature. Botox relaxes the pylorus so that food can empty the stomach more rapidly. Lesser quality studies have shown that this treatment works in about 40% of patients, and relieves symptoms for up to 3 months. This study compares this treatment to placebo (saline) injection. After a 1 month period patients may elect to receive open label botox who have not received relief from their first injection. Patients symptoms and gastric emptying are followed for 1 year.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroparesis
CountriesUnited States
CollaboratorsAmerican College of Gastroenterology

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 7, 2006
Enrollment StartJul 1, 2003
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 19.8 years ago

Interventions

Botulinum toxin Adrug

200 U given by injection into the pylorus.

Placebodrug

saline injection into pylorus.