Clinical trial NCT03328507: A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects
Official title: A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colonoscopy
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2017-11-01
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel preparation prior to colonoscopy in adult patients.


Eligibility criteria: 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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).
* 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 with ongoing severe, acute inflammatory bowel disease.
* Subjects who had previous significant gastrointestinal surgeries.
* Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
* Subjects with uncontrolled hypertension (systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 100 mmHg).
* Subjects with severe renal insufficiency (GFR \< 30 mL/min/1.73m2).
* Subjects with known severe hepatic insufficiency (Child Pugh C).
* Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4).
* 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 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.
* Subjects who withdraw consent before completion of Visit 1 procedures.

Primary outcomes:
measure: % of Subjects With Successful Bowel Preparation
timeFrame: Day of colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Braintree Research Site 1
state: California
city: Chula Vista
country: United States
facility: Braintree Research Site 3
state: California
city: San Diego
country: United States
facility: Braintree Research Site 4
state: California
city: Ogden
country: United States
facility: Braintree Clinical Research Site 2
state: Utah
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References: