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

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: PEG electrolyte lavage solution + bisacodyl; Drug: PEG electrolyte lavage solution + bisacodyl - reformulation

• Study Type: Interventional
• Enrollment (Actual): 308
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
    • Orange, California, United States, 92869
      • Advanced Clinical Research Institute
    • San Diego, California, United States, 92123
      • Medical Associates Research Group
  • Florida
    • New Smyrna Beach, Florida, United States, 32168
      • United Medical Research
  • Maryland
    • Laurel, Maryland, United States, 20707
      • Maryland Digestive Disease Research
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Franklin Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HalfLytely with 10mg bisacodyl; Active control	Drug: PEG electrolyte lavage solution + bisacodyl; multi dose preparation (tablet/solution) for oral administration prior to colonoscopy
Experimental: HalfLytely with 5mg bisacodyl; Investigational dose	Drug: PEG electrolyte lavage solution + bisacodyl - reformulation; multi dose formulation (tablet/solution) for oral administration prior to colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale	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".	during colonoscopy

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: March 5, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 6, 2009

Study Record Updates

• Last Update Posted (Estimate): October 5, 2010
• Last Update Submitted That Met QC Criteria: September 29, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: colonoscopy; bowel preparation
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Pharmaceutical Solutions; Bisacodyl
• Other Study ID Numbers: F38-27