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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

March 5, 2009
September 29, 2010
February 2009
May 2009   (final data collection date for primary outcome measure)
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".
Efficacy: Preparation success based on a 4 point scale [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00857272 on ClinicalTrials.gov Archive Site
Not Provided
Safety: preparation related side effects [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Colonoscopy
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
308
Not Provided
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00857272
F38-27
No
John McGowan, Associate Director, Clinical Research, Braintree Laboratories, Inc.
Braintree Laboratories
Not Provided
Study Director: John McGowan, MPH Braintree Laboratories, Inc.
Braintree Laboratories
September 2010

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