Efficacy Study of Bowel Preparation Before Colonoscopy

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2008

Interventions

  • Drug: FM-601
    • Dose-escalation, split dosage, liquid

Clinical Trial Outcome Measures

Primary Measures

  • Effectiveness of bowel cleansing based on a grading scale.
    • Time Frame: During colonoscopy

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 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

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