Placebo Controlled Trial of Botulinum Toxin for Gastroparesis

Completed · Not applicable · Has a placebo group

Conditions studied: Gastroparesis

In brief

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.

Key facts

Study ID

NCT00372970

Run by

Temple University

People needed

32

Starts

2003-07-01

Expected to finish

2008-12-01

Last updated by the study team

2015-06-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented gastroparesis by radiologic study
• No ulcer disease
• Only surgery history must be either appendectomy or cholecystectomy
• No prior treatment with Botox

You may not qualify if…

• Prior botox injection

Where it is running

• Temple University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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