N/A
N=32
Placebo Controlled Trial of Botulinum Toxin for Gastroparesis
Gastroparesis
Bottom Line
View on ClinicalTrials.gov: NCT00372970 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Symptom Response as Assessed by the Gastroparesis Cardinal Symptom Index. — 6.8; 10.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Botulinum toxin A (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Temple University
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptom Response as Assessed by the Gastroparesis Cardinal Symptom Index. |
6.8; 10.1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00372970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.