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
Recruitment status was Recruiting
Sponsor:
Georgia Regents University
Information provided by:
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01031043
First received: December 10, 2009
Last updated: May 12, 2011
Last verified: May 2011
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ineffective Esophageal Motility |
Drug: Bethanechol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Topical Bethanechol for Improvement of Esophageal Dysmotility: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Georgia Regents University:
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: | 10 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Bethanechol
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031043
Contacts
| Contact: Gregory N Postma, MD | 706-721-6100 | gpostma@mcg.edu |
| Contact: Paul M Weinberger, MD | 706-721-6100 | pweinberger@mcg.edu |
Locations
| United States, Georgia | |
| Medical College of Georgia | Recruiting |
| Augusta, Georgia, United States, 30912 | |
| Contact: Gregory N Postma, MD 706-721-6100 gpostma@mcg.edu | |
| Contact: Paul M Weinberger, MD 706-721-6100 pweinberger@mcg.edu | |
| Principal Investigator: Gregory N Postma, MD | |
Sponsors and Collaborators
Georgia Regents University
Investigators
| Principal Investigator: | Gregory N Postma, MD | Georgia Regents University |
More Information
No publications provided
| Responsible Party: | Gregory Postma, MD, Medical College of Georgia |
| ClinicalTrials.gov Identifier: | NCT01031043 History of Changes |
| Other Study ID Numbers: | 09-03-244 |
| Study First Received: | December 10, 2009 |
| Last Updated: | May 12, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Georgia Regents University:
|
IEM |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Motility Disorders Esophageal Spasm, Diffuse Gastrointestinal Diseases Digestive System Diseases Deglutition Disorders Bethanechol Parasympathomimetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Muscarinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013