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

NCT00857272 | Completed Phase 4 Results

• 1 other identifier: F38-27
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Colonoscopy

Keywords

colonoscopy; bowel preparation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

HalfLytely with 10mg bisacodyl

ACTIVE COMPARATOR

Active control

Drug: PEG electrolyte lavage solution + bisacodyl

HalfLytely with 5mg bisacodyl

EXPERIMENTAL

Investigational dose

Drug: PEG electrolyte lavage solution + bisacodyl - reformulation

Interventions

PEG electrolyte lavage solution + bisacodyl - reformulation DRUG

multi dose formulation (tablet/solution) for oral administration prior to colonoscopy

HalfLytely with 5mg bisacodyl

PEG electrolyte lavage solution + bisacodyl DRUG

multi dose preparation (tablet/solution) for oral administration prior to colonoscopy

HalfLytely with 10mg bisacodyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (6)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Advanced Clinical Research Institute

Orange, California, 92869, United States

Location

Medical Associates Research Group

San Diego, California, 92123, United States

Location

United Medical Research

New Smyrna Beach, Florida, 32168, United States

Location

Maryland Digestive Disease Research

Laurel, Maryland, 20707, United States

Location

Franklin Gastroenterology

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Interventions

Bisacodyl

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Total number of patients experiencing a non-serious adverse event is based on all adverse events, not just those events above the reporting threshold of 3%

Results Point of Contact

• Title: John McGowan, Associate Director, Clinical Research
• Organization: Braintree Laboratories, Inc.

jmcgowan@braintreelabs.com

781-843-2202

Study Officials

• John McGowan, MPH

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2009
• Last Updated: October 5, 2010
• Results First Posted: September 28, 2010

Record last verified: 2010-09

Locations

US (6)