Placebo Controlled Trial of Botulinum Toxin for Gastroparesis

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Collaborator: American College of Gastroenterology
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Documented gastroparesis by radiologic study

• No ulcer disease

• Only surgery history must be either appendectomy or cholecystectomy

• No prior treatment with Botox

Exclusion Criteria:

• Prior botox injection