Study of Efficacy of Bowel Preparation Before Colonoscopy

NCT ID: NCT00771485

Last Updated: 2012-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2008-12-31

Brief Summary

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

Conditions

Bowel Cleansing Prior to Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: EXPERIMENTAL

FM-602

Intervention Type: DRUG

Study of Efficacy of Bowel Preparation Before Colonoscopy

2

Group Type: OTHER

Marketed Bowel Cleanser

Intervention Type: DRUG

Marketed bowel cleanser

Interventions

FM-602

Study of Efficacy of Bowel Preparation Before Colonoscopy

Intervention Type: DRUG

Marketed Bowel Cleanser

Marketed bowel cleanser

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

C.B. Fleet Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherrie McNamara, RN, MSN, MBA

Role: STUDY_DIRECTOR

C.B. Fleet Company, Inc.

Locations

Advanced Clinical Research Institute

Anaheim, California, United States

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Countries

United States

Other Identifiers

PL08.01

Identifier Type: -

Identifier Source: org_study_id