Effect of Yohimbine on Colon Transit

This study has been completed.

First Received: September 16, 2005 Last Updated: April 27, 2009 History of Changes

Sponsor:	Mayo Clinic
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00217048

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: Yohimbine, oral	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Oral Yohimbine on Colonic Transit: Randomized, Placebo-Controlled Trial

Resource links provided by NLM:

Drug Information available for: Yohimbine

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Colonic transit

Secondary Outcome Measures:

Small bowel transit time
Gastric emptying time
Maximum tolerated volume ingested during satiation testing
Average stools per day
Stool consistency

Estimated Enrollment:	30
Study Start Date:	June 2005
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217048

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902

Sponsors and Collaborators

Mayo Clinic

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Adil E Bharucha, MBBS, M.D.

Mayo Clinic

More Information

No publications provided

Study ID Numbers:	275-05
Study First Received:	September 16, 2005
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00217048 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Mydriatics
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Autonomic Agents
Physiological Effects of Drugs

Yohimbine
Adrenergic Antagonists
Peripheral Nervous System Agents
Adrenergic alpha-Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010