Study of Efficacy of Bowel Preparation Before Colonoscopy

C.B. Fleet Company

Status and phase: Completed; Phase 2

Conditions: Bowel Cleansing Prior to Colonoscopy

Treatments: Drug: Marketed Bowel Cleanser; Drug: FM-602

Study type: Interventional

Funder types: Industry

Identifiers

NCT00771485

PL08.01

Details and patient eligibility

About

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

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: FM-602

2

Other group

Treatment:

Drug: Marketed Bowel Cleanser