Topical Bethanechol for Improvement of Esophageal Dysmotility
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | November 2009 |
| End Date: | April 2012 |
| Contact: | Gregory N Postma, MD |
| Email: | gpostma@mcg.edu |
| Phone: | 706-721-6100 |
Topical Bethanechol for Improvement of Esophageal Dysmotility: A Pilot Study
The purpose of this research project is to determine the effect of a drug called bethanechol
on swallowing function in patients with Ineffective Esophageal Motility (IEM). This drug is
FDA approved for use in treating other conditions, but not for the treatment of IEM. There
is currently no approved therapy for the treatment of IEM. This information is important for
the possible development of new ways of treating patients with IEM and for the effectiveness
of topically applied Bethanechol on patients with IEM.
on swallowing function in patients with Ineffective Esophageal Motility (IEM). This drug is
FDA approved for use in treating other conditions, but not for the treatment of IEM. There
is currently no approved therapy for the treatment of IEM. This information is important for
the possible development of new ways of treating patients with IEM and for the effectiveness
of topically applied Bethanechol on patients with IEM.
Inclusion Criteria:
- Any adult patient treated at the Medical College of Georgia, with severe IEM as
defined using current criteria: esophageal contraction amplitude <30 mmHg either 5 or
10 cm above the lower esophageal sphincter, in 50% or more of saline swallows.
Exclusion Criteria:
- Patients with severe comorbidities (including uncontrolled hypertension, severe
coronary artery disease, and uncontrolled diabetes) will be specifically excluded
from the study.
- Additionally, the use of bethanechol (as well as all other muscarinic receptor
agonists) is contraindicated in patients with asthma, coronary insufficiency, peptic
ulcers, Parkinson's disease, seizure disorder, recent gastrointestinal surgery, and
hyperthyroidism. As such any patient with these disorders will be specifically
excluded from this study.
- Women of childbearing age will also be specifically excluded (Bethanechol is listed
as a pregnancy class C drug).
We found this trial at
1
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Med College of Georgia Georgia Regents University, home of the Medical College of Georgia, is...
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