Study of Efficacy of Bowel Preparation Before Colonoscopy

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 2008

Interventions

  • Drug: FM-602
    • Study of Efficacy of Bowel Preparation Before Colonoscopy
  • Drug: Marketed Bowel Cleanser
    • Marketed bowel cleanser

Arms, Groups and Cohorts

  • Experimental: 1
  • Other: 2

Clinical Trial Outcome Measures

Primary Measures

  • Effectiveness of bowel cleansing assessed by the examining physician
    • Time Frame: During colonoscopy

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • C.B. Fleet Company, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sherrie McNamara, RN, MSN, MBA, Study Director, C.B. Fleet Company, Inc.

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