Effect of Yohimbine on Colon Transit

April 27, 2009 updated by: Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Colonic transit

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (ACTUAL)

October 1, 2005

Study Completion (ACTUAL)

October 1, 2005

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2009

Last Update Submitted That Met QC Criteria

April 27, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 275-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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