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Study of Efficacy of Bowel Preparation Before Colonoscopy

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ClinicalTrials.gov Identifier: NCT00771485
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : February 10, 2012
Sponsor:
Information provided by (Responsible Party):

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Study of Efficacy of Bowel Preparation Before Colonoscopy
Study Start Date : September 2008
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: FM-602
Study of Efficacy of Bowel Preparation Before Colonoscopy
2 Drug: Marketed Bowel Cleanser
Marketed bowel cleanser


Outcome Measures

Primary Outcome Measures :
  1. Effectiveness of bowel cleansing assessed by the examining physician [ Time Frame: During colonoscopy ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: October 13, 2008    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012