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A Safety Study of 3 Different Bowel Cleansing Preparations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01501513
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colonoscopy Bowel Preparation Endoscopy Drug: PEG-3350 based bowel preparation Drug: BLI800 approved preparation regimen Drug: BLI800 investigational preparation regimen Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2011
Actual Primary Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: BLI800 approved preparation regimen
BLI800 approved preparation regimen
 Drug: BLI800 approved preparation regimen
solution for oral administration prior to colonoscopy
Experimental: BLI800 investigational preparation regimen
BLI800 investigational preparation regimen
 Drug: BLI800 investigational preparation regimen
solution for oral administration prior to colonoscopy
Active Comparator: PEG-3350 based bowel preparation
PEG-3350 based bowel preparation
 Drug: PEG-3350 based bowel preparation
solution for oral administration prior to colonoscopy


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of adverse events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. % of subjects with successful preparation [ Time Frame: Day of colonoscopy ]
    rated by blinded colonoscopist on 4 point scale (1 = poor to 4 = excellent)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501513


Locations
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Sponsors and Collaborators
Braintree Laboratories
More Information
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Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT01501513    
Other Study ID Numbers: BLI800-440
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014
Keywords provided by Braintree Laboratories:
colonoscopy
bowel preparation
endoscopy
Additional relevant MeSH terms:
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Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents