- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04446312
Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
October 25, 2023 updated by: Braintree Laboratories
A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85712
- 302 Research Site 2
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Arkansas
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Little Rock, Arkansas, United States, 72211
- 302 Research Site 10
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North Little Rock, Arkansas, United States, 72117
- 302 Research Site 11
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California
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Chula Vista, California, United States, 91910
- 302 Research Site 9
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Los Angeles, California, United States, 90036
- 302 Research Site 31
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Connecticut
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Bristol, Connecticut, United States, 06010
- 302 Research Site 22
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Florida
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Fleming Island, Florida, United States, 32003
- 302 Research Site 17
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Inverness, Florida, United States, 34452
- 302 Research Site 3
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Jacksonville, Florida, United States, 32256
- 302 Research Site 14
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Miami, Florida, United States, 33134
- 302 Research Site 28
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Miami, Florida, United States, 33155
- 302 Research Site 29
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Miami, Florida, United States, 33155
- 302 Research Site 30
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Palm Harbor, Florida, United States, 34684
- 302 Research Site 38
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Illinois
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Oak Lawn, Illinois, United States, 60453
- 302 Research Site 5
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- 302 Research Site 34
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Mandeville, Louisiana, United States, 70471
- 302 Research Site 26
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Monroe, Louisiana, United States, 71201
- 302 Research Site 36
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Maryland
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Hagerstown, Maryland, United States, 21742
- 302 Research Site 16
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New York
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Brooklyn, New York, United States, 11235
- 302 Research Site 39
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Great Neck, New York, United States, 11023
- 302 Research Site 37
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North Carolina
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Asheville, North Carolina, United States, 28801
- 302 Research Site 8
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High Point, North Carolina, United States, 27262
- 302 Research Site 25
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Raleigh, North Carolina, United States, 27612
- 302 Research Site 1
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Wilmington, North Carolina, United States, 28403
- 302 Research Site 13
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Ohio
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Cincinnati, Ohio, United States, 45219
- 302 Research Site 18
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Tennessee
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Jackson, Tennessee, United States, 38305
- 302 Research Site 23
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Kingsport, Tennessee, United States, 37660
- 302 Research Site 33
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Texas
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Cedar Park, Texas, United States, 78613
- 302 Research Site 32
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Houston, Texas, United States, 77058
- 302 Research Site 21
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Southlake, Texas, United States, 76092
- 302 Research Site 35
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Webster, Texas, United States, 77598
- 302 Research Site 27
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Virginia
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Charlottesville, Virginia, United States, 22911
- 302 Research Site 6
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Fairfax, Virginia, United States, 22031
- 302 Research Site 4
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Washington
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Bellevue, Washington, United States, 98004
- 302 Research Site 7
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
- 18 to 85 years of age (inclusive)
- If female, and of child-bearing potential, is using an acceptable form of birth control.
- Negative serum 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, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.
- Subjects with inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.
- Subjects who had previous significant gastrointestinal surgeries.
- Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation
- Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
- Subjects taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days.
- Subjects with uncontrolled hypertension.
- Subjects taking antibiotics within 7 days of colonoscopy.
- Subjects with severe renal, hepatic or cardiac insufficiency.
- Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit 1.
- Subjects undergoing insulin therapy for any indication.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects undergoing colonoscopy for foreign body removal and/or decompression.
- Subjects taking tricyclic antidepressants.
- Subjects using drugs of abuse, including abused prescription medications.
- Subjects who are withdrawing from alcohol or benzodiazepines.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: BLI4900
Experimental bowel preparation solution for oral ingestion
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Orally ingested liquid bowel preparation
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Active Comparator: FDA Approved Control
FDA approved bowel preparation solution for oral ingestion
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Orally ingested liquid bowel preparation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects With Successful Bowel Preparation
Time Frame: 2 days
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Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).
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2 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: John McGowan, Braintree Laboratories / Sebela Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2020
Primary Completion (Actual)
January 7, 2021
Study Completion (Actual)
February 5, 2021
Study Registration Dates
First Submitted
June 22, 2020
First Submitted That Met QC Criteria
June 22, 2020
First Posted (Actual)
June 24, 2020
Study Record Updates
Last Update Posted (Actual)
October 27, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- BLI4900-302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colonoscopy
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Borland-Groover ClinicValley Medical Products, LLC is paying for the study and is the sponsor....CompletedColonoscopy | Screening Colonoscopy | Surveillance ColonoscopyUnited States
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Josue AliagaCompleted
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Endostart srlCompleted
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Rambam Health Care CampusUnknownInadequate Preparation for Colonoscopy; Personalized Colonoscopy PreparationIsrael
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Hospital Central Norte PEMEXRecruitingPerformance of Colonoscopy | Tolerance of ColonoscopyMexico
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VA Office of Research and DevelopmentVA Palo Alto Health Care System; VA Northern California Health Care SystemCompletedWater Exchange Colonoscopy | Unsedated Colonoscopy | Cap | Colonoscopy PainUnited States
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Dalin Tzu Chi General HospitalCompletedColonoscopy | Intubation Time | Cap-assisted ColonoscopyTaiwan
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Valduce HospitalCompletedUnsedated Colonoscopy | Warm Water | CO2 ColonoscopyItaly
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Daewoong Pharmaceutical Co. LTD.Not yet recruiting
Clinical Trials on Bowel Prep
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Children's Mercy Hospital Kansas CityUniversity of North CarolinaWithdrawn
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Boston Urogynecology AssociatesUnknown
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Randers Regional HospitalCompleted
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University of British ColumbiaCompletedEfficacy of Bowel Preparation | Ease of Bowel Preparation and Patient TolerabilityCanada
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Karolinska InstitutetCompletedPatient Satisfaction and Efficacy of Bowel-preparationSweden
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Braintree LaboratoriesCompletedColonoscopyUnited States
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Braintree LaboratoriesCompletedEndoscopy | Colonoscopy | Bowel PreparationUnited States
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Medtronic - MITGCompletedCrohn's DiseaseUnited States
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Medtronic - MITGTerminated
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University of Alabama at BirminghamCompletedValue of the Bowel Preparation and Diet Change Versus no Intervention | Preoperative Bowel RegimenUnited States