Efficacy Study of Bowel Preparation Before Colonoscopy

NCT ID: NCT00621920

Last Updated: 2012-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-04-30

Brief Summary

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

Conditions

Bowel Cleansing Prior to Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

FM-601

Dose-escalation, split dosage, liquid

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

C.B. Fleet Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Advanced Clinical Research Institute

Anaheim, California, United States

Qualia Clinical Services

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

PL07.01

Identifier Type: -

Identifier Source: org_study_id