Skip to main content
OpenTrials
Completed

NCT Number: NCT00621920

Efficacy Study of Bowel Preparation Before Colonoscopy

The purpose of this study is to determine the efficacious dose range when used as a bowel preparation before colonoscopy.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Advanced Clinical Research Institute, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and nonpregnant women who are scheduled for an elective colonoscopy and who are at least 50 years of age.
  • Are able to communicate with study personnel and comply with study requirements.
  • Are able and willing to follow study-specified testing, diet, and hydration regimen.
  • Have been informed of the nature and risks of the study and have given written informed consent.

Exclusion criteria

  • Have known or suspected liver disease or any history of abnormal liver function tests.
  • Have clinically active cardiovascular disease within the past 6 months.
  • Have blood pressure greater than 150/90 mm Hg.
  • Have known or suspected renal insufficiency.
  • Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
  • Have a history of prior bowel surgery within 2 years before enrollment, or active inflammatory bowel disease.
  • Have diabetes or a history of diabetes.
  • Have clinical evidence of dehydration.
  • Are pregnant or breast-feeding.
  • Are unwilling to abstain from alcohol consumption from one day before colonoscopy until discharged from the study.
  • Use prohibited medications of the study in the defined timeframes.
  • Have received any investigational agent within 30 days before dosing.
  • Have any known contraindications to the study treatment.
  • Have any known or suspected allergies to the components of the study medication.
  • Have any other condition which would make the subject unsuitable for inclusion in the study.

Treatment and study plan

FM-601

Drug

Dose-escalation, split dosage, liquid

Primary outcomes

  1. Effectiveness of bowel cleansing based on a grading scale.

    Time frame: During colonoscopy

Sponsors and collaborators

Lead sponsor

C.B. Fleet Company, Inc.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2008
Registry last updated
Feb 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.