Status:
COMPLETED
Efficacy Study of Bowel Preparation Before Colonoscopy
Lead Sponsor:
C.B. Fleet Company, Inc.
Conditions:
Bowel Cleansing Prior to Colonoscopy
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacious dose range when used as a bowel preparation before colonoscopy.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00621920
Start Date
January 1 2008
End Date
April 1 2008
Last Update
February 10 2012
Active Locations (2)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
Qualia Clinical Services
Omaha, Nebraska, United States, 68154