F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Phase 4

Completed

• Conditions: Colonoscopy
• Interventions: Drug: PEG electrolyte lavage solution + bisacodyl; Drug: PEG electrolyte lavage solution + bisacodyl - reformulation

• Registration Number: NCT00857272
• Lead Sponsor: Braintree Laboratories

Brief Summary

To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Primary Completion: 2009-05
• Disposition First Submitted: 2010-05-03
• Disposition First Submitted QC: 2010-05-03
• Disposition First Posted: 2010-05-05
• Results First Submitted: 2010-08-09
• Status Verified: 2010-09
• Results First Submitted QC: 2010-09-08
• Results First Posted: 2010-09-28
• Last Update Submitted: 2010-09-29
• Last Update Posted: 2010-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications:
2. At least 18 years of age
3. Otherwise in good health, as determined by physical exam and medical history
4. If female, and of child-bearing potential, is using an acceptable form of birth control
5. Negative urine pregnancy test at screening, if applicable
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria

1. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration
3. Subjects who are undergoing colonoscopy for foreign body removal and decompression
4. Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
5. Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics
6. Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study
8. Subjects of childbearing potential who refuse a pregnancy test
9. Subjects who are allergic to any preparation components
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
11. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HalfLytely with 10mg bisacodyl	PEG electrolyte lavage solution + bisacodyl	Active control
HalfLytely with 5mg bisacodyl	PEG electrolyte lavage solution + bisacodyl - reformulation	Investigational dose

Primary Outcome Measures

Name	Time	Method
Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale	during colonoscopy	Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = "excellent" (no more than small bits of adherent feces/fluid); 3 = "good" (small amounts of feces or fluid not interfering with the exam); 2 = "fair" (enough feces or fluid to prevent a completely reliable exam); 1 = "poor" (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a "success" and grades of 2 or 1 were considered a "failure".

Trial Locations

Locations (5)

Advanced Clinical Research Institute; 🇺🇸 Orange, California, United States

Medical Associates Research Group; 🇺🇸 San Diego, California, United States

Franklin Gastroenterology; 🇺🇸 Franklin, Tennessee, United States

United Medical Research; 🇺🇸 New Smyrna Beach, Florida, United States

Maryland Digestive Disease Research; 🇺🇸 Laurel, Maryland, United States