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

NCT ID: NCT00857272

Last Updated: 2010-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Brief Summary

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

Detailed Description

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Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HalfLytely with 10mg bisacodyl

Active control

Group Type ACTIVE_COMPARATOR

PEG electrolyte lavage solution + bisacodyl

Intervention Type DRUG

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

HalfLytely with 5mg bisacodyl

Investigational dose

Group Type EXPERIMENTAL

PEG electrolyte lavage solution + bisacodyl - reformulation

Intervention Type DRUG

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

Interventions

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PEG electrolyte lavage solution + bisacodyl - reformulation

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

Intervention Type DRUG

PEG electrolyte lavage solution + bisacodyl

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Braintree Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Braintree Laboratories, Inc.

Principal Investigators

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John McGowan, MPH

Role: STUDY_DIRECTOR

Braintree Laboratories, Inc.

Locations

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Advanced Clinical Research Institute

Anaheim, California, United States

Site Status

Advanced Clinical Research Institute

Orange, California, United States

Site Status

Medical Associates Research Group

San Diego, California, United States

Site Status

United Medical Research

New Smyrna Beach, Florida, United States

Site Status

Maryland Digestive Disease Research

Laurel, Maryland, United States

Site Status

Franklin Gastroenterology

Franklin, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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F38-27

Identifier Type: -

Identifier Source: org_study_id