Effect of Yohimbine on Colon Transit

Healthy Volunteers Clinical Trial

Official title:

Effect of Oral Yohimbine on Colonic Transit: Randomized, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217048
• Other study ID #: 275-05
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 16, 2005
• Last updated: April 27, 2009
• Start date: June 2005
• Est. completion date: October 2005

Study information

• Verified date: April 2009
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is being done to learn if yohimbine, a naturally occurring drug, affects the speed at which food travels through the stomach, intestines and colon, and if yohimbine affects the amount of liquid you can drink in a short period of time. Understanding how yohimbine works on the gut may help develop new treatments for patients with constipation. Yohimbine has been approved by the Food and Drug Administration (FDA) for routine clinical use, however, its use as proposed in this study is considered investigational.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

• Healthy male or non-pregnant, non-breastfeeding female volunteers, -18-65 years old;

• Able to provide written informed consent before participating in the study;

• Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Yohimbine, oral

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonic transit
Secondary	Small bowel transit time
Secondary	Gastric emptying time
Secondary	Maximum tolerated volume ingested during satiation testing
Secondary	Average stools per day
Secondary	Stool consistency