Clinical Trial: Topical Bethanechol for Improvement of Esophageal Dysmotility
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Topical Bethanechol for Improvement of Esophageal Dysmotility: A Pilot Study
Brief Summary: 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.
Detailed Summary:
This is a pilot study, and as such is not necessarily expected to achieve statistical significance. A control group will not be used, again owing to the pilot nature of the study. Previous studies have demonstrated the safety of oral bethanechol. It has shown some efficacy in the treatment of gastroesophageal reflux in both adults and children1-8, and there is extensive preclinical data suggesting a beneficial effect for patients with IEM9-14. A single study15 of oral bethanechol in patients with IEM demonstrated a significant improvement in distal esophageal muscle contraction and bolus transit. This study, however measured esophageal function using an inferior method of manometry. The proposed study uses high-resolution manometry to measure the effects of oral bethanechol in patients with IEM, and will yield improved understanding of changes in esophageal function in real-time. The study intervention (oral bethanechol) will be a single-dose event (applied in two encounters), not an ongoing treatment intervention.
We will evaluate the effect of topically applied bethanechol on esophageal motility in a cohort (n=20) of patients with IEM. Presence of IEM will be 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 swallows15, 16. We will perform high-resolution manometry (HRM) to establish a baseline in these patients. HRM is part of the cutting-edge technology available at the Medical College of Georgia Center for Voice and Swallowing Disorders (CVSD, part of the Department of Otolaryngology), and is used in the clinical evaluation of patients with dysphagia on a routine basis. Many patients with IEM referred to the CVSD will undergo high-resolution manometry during the course of their evaluation and treatment, regardless of inclusion in this study. The test consists o
Sponsor: Augusta University
Current Primary Outcome: Distal Contractile Integral [ Time Frame: Encounter 1 (day 1) and Encounter 2 (Month 14) ]
Original Primary Outcome: 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. ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Augusta University
Dates:
Date Received: December 10, 2009
Date Started: November 2009
Date Completion:
Last Updated: January 27, 2015
Last Verified: January 2015