A Safety Study of 3 Different Bowel Cleansing Preparations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT01501513
First received: December 22, 2011
Last updated: July 11, 2014
Last verified: July 2014

December 22, 2011
July 11, 2014
December 2011
April 2013   (final data collection date for primary outcome measure)
Frequency of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01501513 on ClinicalTrials.gov Archive Site
% of subjects with successful preparation [ Time Frame: Day of colonoscopy ] [ Designated as safety issue: No ]
rated by blinded colonoscopist on 4 point scale (1 = poor to 4 = excellent)
Same as current
Not Provided
Not Provided
 
A Safety Study of 3 Different Bowel Cleansing Preparations
A Safety, Tolerance and Efficacy Evaluation of 3 Different Bowel Cleansing Preparations in Adult Subjects, Including the Elderly and Subjects With Hepatic or Renal Insufficiency

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Colonoscopy
  • Bowel Preparation
  • Endoscopy
  • Drug: PEG-3350 based bowel preparation
    solution for oral administration prior to colonoscopy
  • Drug: BLI800 approved preparation regimen
    solution for oral administration prior to colonoscopy
  • Drug: BLI800 investigational preparation regimen
    solution for oral administration prior to colonoscopy
  • Experimental: BLI800 approved preparation regimen
    BLI800 approved preparation regimen
    Intervention: Drug: BLI800 approved preparation regimen
  • Experimental: BLI800 investigational preparation regimen
    BLI800 investigational preparation regimen
    Intervention: Drug: BLI800 investigational preparation regimen
  • Active Comparator: PEG-3350 based bowel preparation
    PEG-3350 based bowel preparation
    Intervention: Drug: PEG-3350 based bowel preparation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
540
Not Provided
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
  • At least 18 years of age
  • 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, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
  • Subjects who had previous significant gastrointestinal surgeries.
  • Subjects who have uncontrolled clinically significant pre-existing electrolyte disturbances.
  • Subjects with severe liver or renal insufficiency.
  • Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality.
  • Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
  • Subjects undergoing colonoscopy for foreign body removal and decompression.
  • Subjects who are pregnant or lactating, or intending to become pregnant during the study.
  • Subjects of childbearing potential who refuse a pregnancy test.
  • Subjects 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 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
 
NCT01501513
BLI800-440
No
Braintree Laboratories
Braintree Laboratories
Not Provided
Not Provided
Braintree Laboratories
July 2014

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