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

This study has been completed.

Sponsor:

Information provided by:

Braintree Laboratories

ClinicalTrials.gov Identifier:

NCT00857272

First received: March 5, 2009

Last updated: September 29, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 5, 2009

Last Updated Date

September 29, 2010

Start Date ^ICMJE

February 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale [ Time Frame: during colonoscopy ] [ Designated as safety issue: No ]

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".

Original Primary Outcome Measures ^ICMJE

Efficacy: Preparation success based on a 4 point scale [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00857272 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Safety: preparation related side effects [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Colonoscopy

Intervention ^ICMJE

Drug: PEG electrolyte lavage solution + bisacodyl - reformulation
multi dose formulation (tablet/solution) for oral administration prior to colonoscopy
Drug: PEG electrolyte lavage solution + bisacodyl
multi dose preparation (tablet/solution) for oral administration prior to colonoscopy

Study Arm (s)

Active Comparator: HalfLytely with 10mg bisacodyl
Active control

Intervention: Drug: PEG electrolyte lavage solution + bisacodyl
Experimental: HalfLytely with 5mg bisacodyl
Investigational dose

Intervention: Drug: PEG electrolyte lavage solution + bisacodyl - reformulation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

308

Completion Date

Not Provided

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00857272

Other Study ID Numbers ^ICMJE

F38-27

Has Data Monitoring Committee

Responsible Party

John McGowan, Associate Director, Clinical Research, Braintree Laboratories, Inc.

Study Sponsor ^ICMJE

Braintree Laboratories

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

John McGowan, MPH

Braintree Laboratories, Inc.

Information Provided By

Braintree Laboratories

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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