Esophageal Dysmotility Clinical Trial
Official title:
Topical Bethanechol for Improvement of Esophageal Dysmotility: A Pilot Study
Verified date | January 2015 |
Source | Georgia Regents University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Georgia | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Georgia Regents University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Distal Contractile Integral | The index of contractile strength of the esophageal smooth muscle. The range of the index being 0 mmHg *s*cm to >10,000 mmHg *s*cm where 0 represents no contractile strength. The index reflects the magnitude of distal esophageal contraction, taking into consideration the length, strength, and duration of the contraction. | Encounter 1 (day 1) and Encounter 2 (Month 14) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03604523 -
Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation
|
N/A |