NCT03404401

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
620

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

23 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

Study Start

First participant enrolled

January 11, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2018

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

September 8, 2021

Completed
Last Updated

September 8, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

January 12, 2018

Results QC Date

May 4, 2021

Last Update Submit

August 12, 2021

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Number and Percentage of Subjects With Successful Bowel Cleansing

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

    Day of colonoscopy

Other Outcomes (4)

  • Abdominal Distension (Solicited Reports)

    2 days

  • Abdominal Pain (Solicited Reports)

    2 days

  • Nausea (Solicited Reports)

    2 days

  • +1 more other outcomes

Study Arms (2)

BLI4700 Bowel Preparation

EXPERIMENTAL
Drug: BLI4700

FDA Approved Bowel Preparation

ACTIVE COMPARATOR
Drug: Polyethylene glycol bowel preparation

Interventions

BLI4700DRUG

Oral bowel preparation

BLI4700 Bowel Preparation
Polyethylene glycol bowel preparationDRUG

Oral bowel preparation

FDA Approved Bowel Preparation

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 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 or 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Braintree Research Site 212

Mobile, Alabama, 36688, United States

Location

Braintree Research Site 204

Tucson, Arizona, 85712, United States

Location

Braintree Research Site 209

Anaheim, California, 92801, United States

Location

Braintree Research Site 219

Chula Vista, California, 91910, United States

Location

Braintree Research Site 206

Los Angeles, California, 90045, United States

Location

Braintree Research Site 220

San Diego, California, 92114, United States

Location

Braintree Research Site 221

Inverness, Florida, 34452, United States

Location

Braintree Research Site 222

Jacksonville, Florida, 32216, United States

Location

Braintree Research Site 201

Palm Harbor, Florida, 34684, United States

Location

Braintree Research Site 224

Atlanta, Georgia, 30342, United States

Location

Braintree Research Site 215

Decatur, Georgia, 30033, United States

Location

Braintree Research Site 223

Lake Charles, Louisiana, 70601, United States

Location

Braintree Research Site 211

Monroe, Louisiana, 71201, United States

Location

Braintree Research Site 207

Hagerstown, Maryland, 21742, United States

Location

Braintree Research Site 218

Flowood, Mississippi, 39232, United States

Location

Braintree Research Site 210

Great Neck, New York, 11023, United States

Location

Braintree Research Site 214

Cincinnati, Ohio, 45219, United States

Location

Braintree Research Site 213

Portland, Oregon, 97210, United States

Location

Braintree Research Site 216

Columbia, South Carolina, 29203, United States

Location

Braintree Research Site 202

Franklin, Tennessee, 37067, United States

Location

Braintree Research Site 203

Jackson, Tennessee, 38305, United States

Location

Braintree Research Site 217

Ogden, Utah, 84405, United States

Location

Braintree Research Site 208

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (1)

  • Di Palma JA, Bhandari R, Cleveland MV, Mishkin DS, Tesoriero J, Hall S, McGowan J. A Safety and Efficacy Comparison of a New Sulfate-Based Tablet Bowel Preparation Versus a PEG and Ascorbate Comparator in Adult Subjects Undergoing Colonoscopy. Am J Gastroenterol. 2021 Feb 1;116(2):319-328. doi: 10.14309/ajg.0000000000001020.

    PMID: 33165006DERIVED

Results Point of Contact

Title
Head of R&D, Gastroenterology
Organization
Braintree Laboratories, Inc.
studydirector@sebelapharma.com
781-843-2202

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 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

January 12, 2018

First Posted

January 19, 2018

Study Start

January 11, 2018

Primary Completion

July 10, 2018

Study Completion

July 10, 2018

Last Updated

September 8, 2021

Results First Posted

September 8, 2021

Record last verified: 2021-05

Locations

US(23)