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
  Purpose

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


Condition Intervention Phase
Colonoscopy
Drug: PEG electrolyte lavage solution + bisacodyl - reformulation
Drug: PEG electrolyte lavage solution + bisacodyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • 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".


Enrollment: 308
Study Start Date: February 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857272

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Advanced Clinical Research Institute
Orange, California, United States, 92869
Medical Associates Research Group
San Diego, California, United States, 92123
United States, Florida
United Medical Research
New Smyrna Beach, Florida, United States, 32168
United States, Maryland
Maryland Digestive Disease Research
Laurel, Maryland, United States, 20707
United States, Tennessee
Franklin Gastroenterology
Franklin, Tennessee, United States, 37067
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John McGowan, MPH Braintree Laboratories, Inc.
  More Information

No publications provided

Responsible Party: John McGowan, Associate Director, Clinical Research, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00857272     History of Changes
Other Study ID Numbers: F38-27
Study First Received: March 5, 2009
Results First Received: August 9, 2010
Last Updated: September 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
colonoscopy
bowel preparation

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014