Study of Efficacy of Bowel Preparation Before Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C.B. Fleet Company, Inc.
ClinicalTrials.gov Identifier:
NCT00771485
First received: October 9, 2008
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Bowel Cleansing Prior to Colonoscopy
Drug: FM-602
Drug: Marketed Bowel Cleanser
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Study of Efficacy of Bowel Preparation Before Colonoscopy

Resource links provided by NLM:


Further study details as provided by C.B. Fleet Company, Inc.:

Primary Outcome Measures:
  • Effectiveness of bowel cleansing assessed by the examining physician [ Time Frame: During colonoscopy ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: FM-602
Study of Efficacy of Bowel Preparation Before Colonoscopy
2 Drug: Marketed Bowel Cleanser
Marketed bowel cleanser

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771485

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, North Carolina
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States, 28304
United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
C.B. Fleet Company, Inc.
Investigators
Study Director: Sherrie McNamara, RN, MSN, MBA C.B. Fleet Company, Inc.
  More Information

No publications provided

Responsible Party: C.B. Fleet Company, Inc.
ClinicalTrials.gov Identifier: NCT00771485     History of Changes
Other Study ID Numbers: PL08.01
Study First Received: October 9, 2008
Last Updated: February 8, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 22, 2014