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.

Study Overview

• Status: Completed
• Conditions: Bowel Cleansing Prior to Colonoscopy
• Intervention / Treatment: Drug: FM-602; Drug: Marketed Bowel Cleanser

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Cumberland Research Associates, LLC
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: FM-602; Study of Efficacy of Bowel Preparation Before Colonoscopy
Other: 2	Drug: Marketed Bowel Cleanser; Marketed bowel cleanser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effectiveness of bowel cleansing assessed by the examining physician	During colonoscopy

Collaborators and Investigators

• Sponsor: C.B. Fleet Company, Inc.
• Investigators: Study Director: Sherrie McNamara, RN, MSN, MBA, C.B. Fleet Company, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: October 9, 2008
• First Submitted That Met QC Criteria: October 10, 2008
• First Posted (Estimate): October 13, 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: PL08.01