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
Sponsor:
Information provided by:
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01031043
First received: December 10, 2009
Last updated: May 12, 2011
Last verified: May 2011
  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
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

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 Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
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 September 18, 2014