Text Size

Efficacy Study of Bowel Preparation Before Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C.B. Fleet Company, Inc.
ClinicalTrials.gov Identifier:
NCT00621920
First received: February 12, 2008
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Bowel Cleansing Prior to Colonoscopy
 Drug: FM-601
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Study of Bowel Preparation Before Colonoscopy

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

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

Primary Outcome Measures:
  • Effectiveness of bowel cleansing based on a grading scale. [ Time Frame: During colonoscopy ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: January 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: FM-601
    Dose-escalation, split dosage, liquid
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621920

Locations
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.
  More Information

No publications provided

Responsible Party: C.B. Fleet Company, Inc.
ClinicalTrials.gov Identifier: NCT00621920     History of Changes
Other Study ID Numbers: PL07.01
Study First Received: February 12, 2008
Last Updated: February 8, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013