Efficacy Study of Bowel Preparation Before Colonoscopy

C.B. Fleet Company

Status and phase

Completed

Phase 2

Conditions

Bowel Cleansing Prior to Colonoscopy

Treatments

Drug: FM-601

Study type

Interventional

Funder types

Industry

Identifiers

PL07.01

Details and patient eligibility

About

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

Enrollment

72 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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.