Efficacy Study of Bowel Preparation Before Colonoscopy

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. Identifier: NCT00621920
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : February 10, 2012
Information provided by (Responsible Party):
C.B. Fleet Company, Inc.

Brief Summary:
The purpose of this study is to determine the efficacious dose range when used as a bowel preparation before colonoscopy.

Condition or disease Intervention/treatment Phase
Bowel Cleansing Prior to Colonoscopy Drug: FM-601 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Study of Bowel Preparation Before Colonoscopy
Study Start Date : January 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Intervention Details:
    Drug: FM-601
    Dose-escalation, split dosage, liquid

Primary Outcome Measures :
  1. Effectiveness of bowel cleansing based on a grading scale. [ Time Frame: During colonoscopy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men and nonpregnant women who are scheduled for an elective colonoscopy and who are at least 50 years of age.
  • Are able to communicate with study personnel and comply with study requirements.
  • Are able and willing to follow study-specified testing, diet, and hydration regimen.
  • Have been informed of the nature and risks of the study and have given written informed consent.

Exclusion Criteria:

  • Have known or suspected liver disease or any history of abnormal liver function tests.
  • Have clinically active cardiovascular disease within the past 6 months.
  • Have blood pressure greater than 150/90 mm Hg.
  • Have known or suspected renal insufficiency.
  • Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
  • Have a history of prior bowel surgery within 2 years before enrollment, or active inflammatory bowel disease.
  • Have diabetes or a history of diabetes.
  • Have clinical evidence of dehydration.
  • Are pregnant or breast-feeding.
  • Are unwilling to abstain from alcohol consumption from one day before colonoscopy until discharged from the study.
  • Use prohibited medications of the study in the defined timeframes.
  • Have received any investigational agent within 30 days before dosing.
  • Have any known contraindications to the study treatment.
  • Have any known or suspected allergies to the components of the study medication.
  • Have any other condition which would make the subject unsuitable for inclusion in the study.

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 identifier (NCT number): NCT00621920

United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, Nebraska
Qualia Clinical Services
Omaha, Nebraska, United States, 68154
Sponsors and Collaborators
C.B. Fleet Company, Inc.

Responsible Party: C.B. Fleet Company, Inc. Identifier: NCT00621920     History of Changes
Other Study ID Numbers: PL07.01
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012