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Study of Efficacy of Bowel Preparation Before Colonoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00771485
First Posted: October 13, 2008
Last Update Posted: February 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
C.B. Fleet Company, Inc.
  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 (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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: C.B. Fleet Company, Inc.
ClinicalTrials.gov Identifier: NCT00771485     History of Changes
Other Study ID Numbers: PL08.01
First Submitted: October 9, 2008
First Posted: October 13, 2008
Last Update Posted: February 10, 2012
Last Verified: February 2012