A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

NCT03261960 — Phase 3, Completed, 389 participants, Braintree Laboratories

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RegistryNCT03261960
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment389 (Actual)
SponsorBraintree Laboratories (Industry)
ConditionsColonoscopy
InterventionsBLI4700, Magnesium bowel preparation (Drug)
Datesstart 2017-08-08, primary completion 2018-03-26, completion 2018-03-26, first posted 2017-08-25, last updated 2021-09-08
Locations20 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Colonoscopy All trials of BLI4700 All trials of Magnesium bowel preparation

-Summary

The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.

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+Arms and interventions

ArmTypeInterventionsDescription
Experimental ArmExperimentalDrug: BLI4700BLI4700 Bowel Preparation
Control ArmActive comparatorDrug: Magnesium bowel preparationFDA Approved Bowel Preparation
  • BLI4700 (Drug): Oral bowel preparation
  • Magnesium bowel preparation (Drug): Oral bowel preparation

+Outcome measures

Primary outcomes

  • Number and Percentage of Subjects With Successful Bowel Cleansing [Day of colonoscopy]: % of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)

Other outcomes

  • Abdominal Pain (Solicited Reports) [2 days]: Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
  • Abdominal Distension (Solicited Reports) [2 days]: Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
  • Nausea (Solicited Reports) [2 days]: Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
  • Vomiting (Solicited Reports) [2 days]: Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event.

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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 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 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 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. NSAID use for occasional pain is not exclusionary.
* Subjects with uncontrolled hypertension (systolic blood pressure > 170 mmHg and diastolic blood pressure > 100 mmHg).
* Subjects taking antibiotics within 7 days of colonoscopy.
* 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 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 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 component.
* Subjects using drugs of abuse, including abused prescription medications.
* Subjects who are withdrawing from alcohol or benzodiazepines.
* 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.

+Posted results

Participant flow

MilestoneExperimental ArmControl Arm
Started190199
Completed176185
Not completed1414

Outcome results

  • Number and Percentage of Subjects With Successful Bowel Cleansing (Primary), Count of participants, Participants: Experimental Arm 175; Control Arm 174 (p <0.001)
  • Abdominal Pain (Solicited Reports) (Other pre specified), Number, percentage of patients: Experimental Arm 82; Control Arm 100
  • Abdominal Distension (Solicited Reports) (Other pre specified), Number, percentage of patients: Experimental Arm 73; Control Arm 69
  • Nausea (Solicited Reports) (Other pre specified), Number, percentage of patients: Experimental Arm 74; Control Arm 94
  • Vomiting (Solicited Reports) (Other pre specified), Number, percentage of patients: Experimental Arm 53; Control Arm 33

Adverse events

Time frame: 30 days

ArmDeathsSerious adverse eventsOther adverse events
Experimental Arm0/190 (0.0%)0/190 (0.0%)5/190 (2.6%)
Control Arm0/199 (0.0%)1/199 (0.5%)2/199 (1.0%)

Serious adverse events by term

TermOrgan systemExperimental ArmControl Arm
CholelithiasisHepatobiliary disorders0/1901/199

Other adverse events by term

TermOrgan systemExperimental ArmControl Arm
Liver function test increasedInvestigations5/1902/199

+Locations (20)

FacilityCityCountryStatus
Braintree Research Site 119Dothan, AlabamaUnited States
Braintree Research Site 117Tucson, ArizonaUnited States
Braintree Research Site 108Little Rock, ArkansasUnited States
Braintree Research Site 110Little Rock, ArkansasUnited States
Braintree Research Site 139Palmetto Bay, FloridaUnited States
Braintree Research Site 124Oak Lawn, IllinoisUnited States
Braintree Research Site 134Indianapolis, IndianaUnited States
Braintree Research Site 112Chevy Chase, MarylandUnited States
Braintree Research Site 141Towson, MarylandUnited States
Braintree Research Site 125Chesterfield, MissouriUnited States
Braintree Research Site 102St Louis, MissouriUnited States
Braintree Research Site 145Egg Harbor, New JerseyUnited States
Braintree Research Site 114Poughkeepsie, New YorkUnited States
Braintree Research Site 105Asheville, North CarolinaUnited States
Braintree Research Site 115Charlotte, North CarolinaUnited States
Braintree Research Site 137Raleigh, North CarolinaUnited States
Braintree Research Site 101Raleigh, North CarolinaUnited States
Braintree Research Site 107Greenville, South CarolinaUnited States
Braintree Research Site 131Charlottesville, VirginiaUnited States
Braintree Research Site 121Bellevue, WashingtonUnited States

+Study documents

+Investigators