Effect of Yohimbine on Colon Transit - Tabular View

Tracking Information

First Received Date ^ICMJE

September 16, 2005

Last Updated Date

April 27, 2009

Start Date ^ICMJE

June 2005

Primary Completion Date

October 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Colonic transit

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00217048 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect of Yohimbine on Colon Transit

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Drug: Yohimbine, oral

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2005

Primary Completion Date

October 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00217048

Responsible Party

Study ID Numbers ^ICMJE

275-05

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Adil E Bharucha, MBBS, M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP