Topical Bethanechol for Improvement of Esophageal Dysmotility
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Georgia Regents University.
Recruitment status was Recruiting
Information provided by:
Georgia Regents University
First received: December 10, 2009
Last updated: May 12, 2011
Last verified: May 2011
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.
Ineffective Esophageal Motility
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Topical Bethanechol for Improvement of Esophageal Dysmotility: A Pilot Study
Primary Outcome Measures:
- Hypothesis is that topically applied bethanechol will improve esophageal smooth muscle contractility and bolus transit in patients with severe IEM. [ Time Frame: The study will involve 1 visit, which will last approximately 45 minutes. ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2012 (Final data collection date for primary outcome measure)
Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031043
|Medical College of Georgia
|Augusta, Georgia, United States, 30912 |
|Contact: Gregory N Postma, MD 706-721-6100 firstname.lastname@example.org |
|Contact: Paul M Weinberger, MD 706-721-6100 email@example.com |
|Principal Investigator: Gregory N Postma, MD |
Georgia Regents University
||Gregory N Postma, MD
||Georgia Regents University
No publications provided
||Gregory Postma, MD, Medical College of Georgia
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 10, 2009
||May 12, 2011
||United States: Food and Drug Administration
Keywords provided by Georgia Regents University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014
Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs