Placebo Controlled Trial of Botulinum Toxin for Gastroparesis

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.

Timeline

Start

2003-07

Primary completion

2008-12

Completion

2008-12

Publications

• Results Friedenberg FK, Palit A, Parkman HP, Hanlon A, Nelson DB. Botulinum toxin A for the treatment of delayed gastric emptying. Am J Gastroenterol. 2008 Feb;103(2):416-23. doi: 10.1111/j.1572-0241.2007.01676.x. Epub 2007 Dec 5.

Drugs

Indications