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.

Study Overview

• Status: Completed
• Conditions: Bowel Cleansing Prior to Colonoscopy
• Intervention / Treatment: Drug: FM-601

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68154
      • Qualia Clinical Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effectiveness of bowel cleansing based on a grading scale.	During colonoscopy

Collaborators and Investigators

• Sponsor: C.B. Fleet Company, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: February 12, 2008
• First Submitted That Met QC Criteria: February 21, 2008
• First Posted (Estimate): February 22, 2008

Study Record Updates

• Last Update Posted (Estimate): February 10, 2012
• Last Update Submitted That Met QC Criteria: February 8, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: PL07.01