View Clinical Trial (Medical Research Study)
Topical Bethanechol for Improvement of Esophageal Dysmotility: A Pilot Study
| City: |
|
Augusta |
| State: |
|
Georgia |
| Zip Code: |
|
30912 |
| Conditions: |
|
Ineffective Esophageal Motility |
| Purpose: |
|
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.
|
| Study Summary: |
|
|
| Criteria: |
|
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).
|
| NCT ID: |
|
NCT01031043 |
| Primary Contact: |
|
Principal Investigator
Gregory N Postma, MD
Georgia Health Sciences University
Gregory N Postma, MD
Phone: 706-721-6100
Email: gpostma@mcg.edu
|
| Backup Contact: |
|
Email: pweinberger@mcg.edu
Paul M Weinberger, MD
Phone: 706-721-6100
|
| Location Contact: |
|
Augusta, Georgia 30912
United States
Gregory N Postma, MD
Phone: 706-721-6100
Email: gpostma@mcg.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 25, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|