A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

NCT03328507 — Phase 2, Completed, 121 participants, Braintree Laboratories

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RegistryNCT03328507
StatusCompleted
PhasePhase 2
Study typeInterventional; non randomized, sequential, masking: none, treatment
Enrollment121 (Actual)
SponsorBraintree Laboratories (Industry)
ConditionsColonoscopy
InterventionsBLI4900, PEG Control (Drug)
Datesstart 2017-11-09, primary completion 2019-11-12, completion 2019-11-12, first posted 2017-11-01, last updated 2023-10-24
Locations4 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Colonoscopy All trials of BLI4900 All trials of PEG Control

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
BLI4900ExperimentalDrug: BLI4900BLI4900 Bowel Preparation
PEG ControlActive comparatorDrug: PEG ControlPolyethylene glycol-based bowel preparation
  • BLI4900 (Drug): BLI4900 Bowel Preparation
  • PEG Control (Drug): Polyethylene glycol-based bowel preparation

+Outcome measures

Primary outcomes

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

+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 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.

+Posted results

Participant flow

MilestoneBLI4900-3BLI4900-5BLI4900-6PEG-SD
Started21404119
Completed21404019
Not completed0010

Outcome results

  • % of Subjects With Successful Bowel Preparation (Primary), Count of participants, Participants: BLI4900-3 17; BLI4900-5 37; BLI4900-6 37; PEG-SD 16

Adverse events

Time frame: 2 days

ArmDeathsSerious adverse eventsOther adverse events
BLI4900-30/21 (0.0%)0/21 (0.0%)13/21 (61.9%)
BLI4900-50/40 (0.0%)0/40 (0.0%)31/40 (77.5%)
BLI4900-60/41 (0.0%)0/41 (0.0%)13/41 (31.7%)
PEG-SD0/19 (0.0%)1/19 (5.3%)14/19 (73.7%)

Serious adverse events by term

TermOrgan systemBLI4900-3BLI4900-5BLI4900-6PEG-SD
diverticulitisGastrointestinal disorders0/210/400/411/19

Other adverse events by term

TermOrgan systemBLI4900-3BLI4900-5BLI4900-6PEG-SD
abdominal distensionGastrointestinal disorders11/2126/408/4110/19
abdominal pain upperGastrointestinal disorders7/2117/406/415/19
nauseaGastrointestinal disorders7/2119/405/417/19
vomitingGastrointestinal disorders3/212/403/411/19
hypernatremiaMetabolism and nutrition disorders0/210/400/411/19
headacheNervous system disorders2/210/400/410/19
migraineNervous system disorders1/210/400/410/19
orthostatic hypotensionVascular disorders1/211/400/410/19

+Locations (4)

FacilityCityCountryStatus
Braintree Research Site 1Anaheim, CaliforniaUnited States
Braintree Research Site 3Chula Vista, CaliforniaUnited States
Braintree Research Site 4San Diego, CaliforniaUnited States
Braintree Clinical Research Site 2Ogden, UtahUnited States

+Publications

  • Results publication: Wiener G, Winkle P, McGowan JD, Cleveland MV, Di Palma JA. A Phase 2 evaluation of a new flavored peg and sulfate solution compared to an over-the-counter laxative, peg and sports drink bowel preparation combination. BMC Gastroenterol. 2023 Dec 11;23(1):433. doi: 10.1186/s12876-023-03069-8. PMID 38082231

+Study documents

+Investigators