Topical Bethanechol for Improvement of Esophageal Dysmotility

NCT01031043 | Completed Phase 1 Results DMC

• 1 other identifier: 09-03-244
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Dysmotility

Keywords

IEM

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Topical Bethanechol

EXPERIMENTAL

patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device

Drug: Bethanechol

Interventions

Bethanechol DRUG

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.

Also known as: Urecholine

Topical Bethanechol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Esophageal Motility Disorders

Interventions

Bethanechol

Condition Hierarchy (Ancestors)

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Bethanechol Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Results Point of Contact

• Title: Gregory N. Postma MD
• Organization: Georgia Regents University

gpostmat@gru.edu

706-721-6100

Study Officials

• Gregory N Postma, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 14, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 29, 2015
• Results First Posted: January 29, 2015

Record last verified: 2015-01

Locations

US (1)