NCT03328507

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

November 9, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2019

Completed
4 years until next milestone

Results Posted

Study results publicly available

October 24, 2023

Completed
Last Updated

October 24, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

October 30, 2017

Results QC Date

September 29, 2023

Last Update Submit

September 29, 2023

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • % of Subjects With Successful Bowel Preparation

    % of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)

    Day of colonoscopy

Study Arms (2)

BLI4900

EXPERIMENTAL

BLI4900 Bowel Preparation

Drug: BLI4900

PEG Control

ACTIVE COMPARATOR

Polyethylene glycol-based bowel preparation

Drug: PEG Control

Interventions

BLI4900DRUG

BLI4900 Bowel Preparation

BLI4900
PEG ControlDRUG

Polyethylene glycol-based bowel preparation

PEG Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Braintree Research Site 1

Anaheim, California, 92801, United States

Location

Braintree Research Site 3

Chula Vista, California, 91910, United States

Location

Braintree Research Site 4

San Diego, California, 92114, United States

Location

Braintree Clinical Research Site 2

Ogden, Utah, 84405, United States

Location

Related Publications (1)

  • 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: 38082231DERIVED

Results Point of Contact

Title
Head of R&D, GI
Organization
Braintree Laboratories, Inc.
studydirector@sebelapharma.com
7818432202

Study Officials

  • John McGowan, MPH

    Braintree Laboratories, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 1, 2017

Study Start

November 9, 2017

Primary Completion

November 12, 2019

Study Completion

November 12, 2019

Last Updated

October 24, 2023

Results First Posted

October 24, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(4)