Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE March 31, 2017
First Posted Date  ICMJE April 6, 2017
Last Update Posted Date September 28, 2018
Actual Study Start Date  ICMJE February 16, 2017
Actual Primary Completion Date April 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
% 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
Frequency of adverse events [ Time Frame: 7 days ]
Frequency of treatment emergent adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Official Title  ICMJE A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colonoscopy
Intervention  ICMJE Drug: BLI4700
BLI4700 Bowel Preparation
Study Arms  ICMJE Experimental: BLI4700
BLI4700 Bowel Preparation
Intervention: Drug: BLI4700
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2018)
17
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2017)
60
Actual Study Completion Date  ICMJE April 10, 2017
Actual Primary Completion Date April 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03103581
Other Study ID Numbers  ICMJE BLI4700-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Braintree Laboratories
Study Sponsor  ICMJE Braintree Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John McGowan, MPH Braintree Laboratories, Inc.
PRS Account Braintree Laboratories
Verification Date September 2018

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