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Placebo Controlled Trial of Botulinum Toxin for Gastroparesis

NCT00372970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-06-09

Study results available
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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.

Conditions

Interventions

DRUG

Botulinum toxin A

200 U given by injection into the pylorus.

DRUG

Placebo

saline injection into pylorus.

Sponsors & Collaborators

  • American College of Gastroenterology

    collaborator OTHER

  • Temple University

    lead OTHER

Principal Investigators

  • Frank K Friedenberg, MD · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00372970 on ClinicalTrials.gov