Expired Study
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Chesapeake, Virginia 23320


Purpose:

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


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.


NCT ID:

NCT00771485


Primary Contact:

Study Director
Sherrie McNamara, RN, MSN, MBA
C.B. Fleet Company, Inc.


Backup Contact:

N/A


Location Contact:

Chesapeake, Virginia 23320
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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