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BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

NCT03103581 — Phase 2, Completed, 17 participants, Braintree Laboratories

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A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

RegistryNCT03103581
StatusCompleted
PhasePhase 2
Study typeInterventional; na, single group, masking: none, treatment
Enrollment17 (Actual)
SponsorBraintree Laboratories (Industry)
ConditionsColonoscopy
InterventionsBLI4700 (Drug)
Datesstart 2017-02-16, primary completion 2017-04-10, completion 2017-04-10, first posted 2017-04-06, last updated 2023-11-15
Locations2 sites in United States

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
BLI4700ExperimentalDrug: BLI4700BLI4700 Bowel Preparation (Investigational Regimen)
  • BLI4700 (Drug): BLI4700 Bowel Preparation (Investigational Regimen)

+Outcome measures

Primary outcomes

  • Proportion of Subjects With Successful Bowel Preparation [Day of colonoscopy]: 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).

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Posted results

Participant flow

MilestoneBLI4700
Started17
Completed15
Not completed2

Outcome results

  • Proportion of Subjects With Successful Bowel Preparation (Primary), Count of participants, Participants: BLI4700 15

Adverse events

Time frame: 2 days

ArmDeathsSerious adverse eventsOther adverse events
BLI47000/17 (0.0%)0/17 (0.0%)14/17 (82.4%)

Other adverse events by term

TermOrgan systemBLI4700
abdominal distensionGastrointestinal disorders10/17
abdominal painGastrointestinal disorders1/17
abdominal pain upperGastrointestinal disorders4/17
nauseaGastrointestinal disorders8/17
vomitingGastrointestinal disorders6/17

+Locations (2)

FacilityCityCountryStatus
Braintree Research Site 1Anaheim, CaliforniaUnited States
Braintree Research Site 2Bastrop, LouisianaUnited States

+Study documents

+Investigators

My Notes