Bowel Cleansing Prior to Colonoscopy
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness of FM-602 as a bowel preparation before colonoscopy.
Interventions
DRUGFM-602
Study of Efficacy of Bowel Preparation Before Colonoscopy
DRUGMarketed Bowel Cleanser
Marketed bowel cleanser
Sponsors
C.B. Fleet Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of bowel cleansing assessed by the examining physician | During colonoscopy |
Countries
United States
Outcome results
None listed