NCT04446299

Brief Summary

The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations 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
519

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

25 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

June 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

July 13, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

October 24, 2023

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

June 22, 2020

Results QC Date

September 29, 2023

Last Update Submit

October 25, 2023

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Proportion of Subjects With Successful Bowel Preparation

    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).

    2 days

Study Arms (2)

BLI4900

EXPERIMENTAL

Experimental bowel preparation solution for oral ingestion

Drug: Bowel Prep

FDA Approved Control

ACTIVE COMPARATOR

FDA approved bowel preparation solution for oral ingestion

Drug: Bowel Prep

Interventions

Bowel PrepDRUG

Orally ingested liquid bowel preparation

BLI4900FDA Approved 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.
  • 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

You may not qualify if:

  • Subjects with known or suspected ileus, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.
  • Subjects with inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.
  • Subjects who had previous significant gastrointestinal surgeries.
  • Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation
  • 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.
  • Subjects with uncontrolled hypertension.
  • Subjects taking antibiotics within 7 days of colonoscopy.
  • Subjects with severe renal, hepatic or cardiac insufficiency.
  • 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 taking tricyclic antidepressants.
  • Subjects using drugs of abuse, including abused prescription medications.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

301 Research Site 18

Huntsville, Alabama, 38501, United States

Location

301 Research Site 24

Sun City, Arizona, 85351, United States

Location

301 Research Site 7

San Diego, California, 92114, United States

Location

301 Research Site 16

Clearwater, Florida, 33756, United States

Location

301 Research Site 12

Jacksonville, Florida, 32216, United States

Location

301 Research Site 9

Palm Harbor, Florida, 34684, United States

Location

301 Research Site 4

Palmetto Bay, Florida, 33157, United States

Location

301 Research Site 26

Port Orange, Florida, 32127, United States

Location

301 Research Site 14

St. Petersburg, Florida, 33709, United States

Location

301 Research Site 25

Sunrise, Florida, 33351, United States

Location

301 Research Site 2

Decatur, Georgia, 30033, United States

Location

301 Research Site 10

Indianapolis, Indiana, 46202, United States

Location

301 Research Site 3

Monroe, Louisiana, 71201, United States

Location

301 Research Site 17

Shreveport, Louisiana, 71105, United States

Location

301 Research Site 11

Flowood, Mississippi, 39232, United States

Location

301 Research Site 13

Chesterfield, Missouri, 48047, United States

Location

301 Research Site 19

Reno, Nevada, 89511, United States

Location

301 Research Site 15

Brooklyn, New York, 11235, United States

Location

301 Research Site 5

Great Neck, New York, 11023, United States

Location

301 Research Site 23

New York, New York, 10033, United States

Location

301 Research Site 6

Raleigh, North Carolina, 27612, United States

Location

301 Research Site 21

Mentor, Ohio, 44060, United States

Location

301 Research Site 20

Hixson, Tennessee, 37434, United States

Location

301 Research Site 1

Ogden, Utah, 84405, United States

Location

301 Research Site 22

Milwaukee, Wisconsin, 53215, United States

Location

Results Point of Contact

Title
Head of R&D, GI
Organization
Braintree Laboratories, Inc.
studydirector@sebelapharma.com
7819646710

Study Officials

  • John McGowan

    Braintree Laboratories / Sebela Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 24, 2020

Study Start

July 13, 2020

Primary Completion

December 22, 2020

Study Completion

January 22, 2021

Last Updated

November 7, 2023

Results First Posted

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(25)