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Completed

NCT Number: NCT00771485

Study of Efficacy of Bowel Preparation Before Colonoscopy

The purpose of this study is to evaluate the effectiveness of FM-602 as a bowel preparation before colonoscopy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Advanced Clinical Research Institute, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are men or nonpregnant women who are scheduled for an elective colonoscopy and who are at least 18 years of age,
  • Are, in the opinion of the Investigator, able to communicate with study personnel and comply with the requirements of the study,
  • Are able and willing to follow the study-specified testing including the diet and hydration regimen, and
  • Have been informed of the nature and risks of the study and have given written informed consent at Screening and before any study-related tests are done.

Exclusion criteria

  • Have any known contraindications to the study procedures or treatment,
  • Have clinically significant active cardiovascular disease, including a history of myocardial infarction, within the past 6 months and/or heart failure
  • Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus,
  • Have any history of prior colon surgery,
  • History of active inflammatory bowel disease,
  • Have clinical evidence of dehydration,
  • Are pregnant or breast-feeding,
  • Are unwilling to abstain from alcohol consumption from the day before colonoscopy until discharged from the study,
  • Are unwilling to use any prohibited medications, including laxatives, 4 days before receiving the first study dose,
  • Have received any investigational agent within 30 days before dosing,
  • Have any known or suspected allergies, sensitivity or an unwillingness to consume components of the study medication,
  • Known or suspected phenylketonuria (PKU) or sensitivity to products containing phenylalanine, or is on a phenylalanine-reduced diet,
  • A history of hemolysis or taking concomitant medications known to precipitate hemolytic reactions,
  • Have any other condition which in the Investigator's opinion would make the subject unsuitable for inclusion into the study.

Treatment and study plan

FM-602

Drug

Study of Efficacy of Bowel Preparation Before Colonoscopy

Marketed Bowel Cleanser

Drug

Marketed bowel cleanser

Primary outcomes

  1. Effectiveness of bowel cleansing assessed by the examining physician

    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
Oct 13, 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.

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