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BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

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: NCT03103581
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Brief Summary:
The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: BLI4700 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Actual Study Start Date : February 16, 2017
Actual Primary Completion Date : April 10, 2017
Actual Study Completion Date : April 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: BLI4700
BLI4700 Bowel Preparation
Drug: BLI4700
BLI4700 Bowel Preparation




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


Secondary Outcome Measures :
  1. Frequency of adverse events [ Time Frame: 7 days ]
    Frequency of treatment emergent adverse events



Information from the National Library of Medicine

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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

Primary Inclusion Criteria:

  1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
  2. At least 18 years of age
  3. If female, and of child-bearing potential, is using an acceptable form of birth control.
  4. Negative urine pregnancy test at screening, if applicable
  5. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Primary Exclusion Criteria:

  1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
  2. Subjects who had previous significant gastrointestinal surgeries.
  3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
  4. Subjects with a prior history of renal, liver or cardiac insufficiency
  5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
  6. Subjects undergoing colonoscopy for foreign body removal and/or decompression.
  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 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 surgical, drug, or device study within the past 30 days.

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): NCT03103581


Locations
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United States, California
Braintree Research Site 1
Anaheim, California, United States, 92801
United States, Louisiana
Braintree Research Site 2
Bastrop, Louisiana, United States, 71220
Sponsors and Collaborators
Braintree Laboratories
Investigators
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Study Director: John McGowan, MPH Braintree Laboratories, Inc.
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Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT03103581    
Other Study ID Numbers: BLI4700-202
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No