ColonoscopyPhase 3NCT02819323

A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy

A Phase 3 study testing PEG-ELS and BLI800 in people with Colonoscopy, run by Braintree Laboratories at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients. Read more about this study

Who is it for?: Ages 12 to 16 years
Conditions the study is for: Colonoscopy
What is being tested?: PEG-ELS and BLI800
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 27 sitesUnited States
Study dates: Jun 2016to 27 Mar 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female between the ages of 12 to 16 (inclusive)
Undergoing colonoscopy for routinely accepted indications, including (but not limited to):
Subjected inflammatory bowel disease (IBD) or IBD follow-up
Lower gastrointestinal bleeding
Suspected colitis (allergic or other)
Abdominal pain

Show all 14Show fewer

Chronic diarrhea
Cancer surveillance
Anemia of unknown etiology
Abnormal endosonography or manometry
Evaluation of barium enema results
If female, and of child-bearing potential, subject must use an acceptable form of birth control or remain abstinent for the duration of the study.
Negative pregnancy test at screening, if applicable
In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.

Who cannot join

Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.
Subjects who had previous significant gastrointestinal surgeries.
Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.
Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, uncorrected dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
Subjects with a prior history of renal, liver or cardiac insufficiency (including congestive heart failure or other significant cardiac abnormality)

Show all 19Show fewer

Subjects with estimated glomerular filtration rate (GFR) below normal range (less than 70 ml/min/1.73m2)
Subjects required to take any other oral medication within 3 hours of dosing until completion of both doses.
Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
Subjects with tendency for nausea and/or vomiting, or that have known swallowing disorders.
Subjects for whom intake of substances is likely to affect gastrointestinal motility or urinary flow rate.
Subjects undergoing colonoscopy for foreign body removal and/or decompression.
Subjects with an abnormal ECG result at Visit 1.
Subjects who are pregnant or lactating, or intending to become pregnant during the study.
Subjects of childbearing potential who refuse a pregnancy test.
Subjects with a history of hypersensitivity 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 and history of major medical/psychiatric conditions that would compromise the safety of the study.
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.

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Braintree Research Site 2
Atlanta, Georgia, 30342
Braintree Research Site 9
Buffalo, New York, 14222
Braintree Research Site 10
Burlington, Vermont, 05401
Braintree Research Site 13
Chicago, Illinois, 60611
Braintree Research Site 1
Flowood, Mississippi, 39232
Braintree Research Site 5
Gainesville, Florida, 32610
Braintree Research Site 26
Indianapolis, Indiana, 46202
Braintree Research Site 24
Jacksonville, Florida, 32207
Braintree Research Site 20
Memphis, Tennessee, 38103
Braintree Research Site 14
Milwaukee, Wisconsin, 53226
Braintree Research Site 25
Minneapolis, Minnesota, 55454
Braintree Research Site 27
Mobile, Alabama, 36582
Braintree Research Site 28
New York, New York, 10021
Braintree Research Site 19
New York, New York, 10032
Braintree Research Site 17
Norfolk, Virginia, 23507
Braintree Research Site 23
Orange, California, 92868
Braintree Research Site 21
Orlando, Florida, 32806
Braintree Research Site 3
Park Ridge, Illinois, 60068
Braintree Research Site 6
Pittsburgh, Pennsylvania, 15224
Braintree Research Site 34
Plano, Texas, 75093
Braintree Research Site 4
Roanoke, Virginia, 24013
Braintree Research Site 18
Rochester, Minnesota, 55905
Braintree Research Site 22
Salt Lake City, Utah, 84118
Braintree Research Site 16
San Francisco, California, 94158
Braintree Research Site 11
Seattle, Washington, 98105
Braintree Research Site 32
The Bronx, New York, 10467
Braintree Research Site 30
Tucson, Arizona, 85724

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About this study

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients.

Conditions: Colonoscopy
Being tested: PEG-ELS, BLI800

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PEG-ELSDrug
polyethylene glycol based bowel preparation
BLI800Drug
BLI800 bowel preparation

Study groups in NCT02819323
Study group	Role	What they receive
BLI800 high dose	Experimental	BLI800 bowel preparation (high dose) Receives: Drug: BLI800
BLI800 low dose	Experimental	BLI800 bowel preparation (low dose) Receives: Drug: BLI800
PEG-ELS	Active comparator	PEG based bowel preparation Receives: Drug: PEG-ELS

What is being measured

The primary outcome is the main question the study is designed to answer.

Number and Percentage of Subjects With Successful Bowel Cleansing
Cleansing is rated by a blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)
Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201627 Mar 2018

First posted30 Jun 2016 (estimated)
Study startJun 2016
Primary completion27 Mar 2018
Study completion27 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ColonoscopyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02819323
Sponsor's protocol ID: BLI800-502
Status last verified: Apr 2021
First submitted: 28 Jun 2016
Last updated: 3 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
ClinicalTrials.gov ID: NCT02819323
Acronym / sponsor ID: BLI800-502
Conditions: Colonoscopy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Braintree LaboratoriesIndustry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: 27 Mar 2018 (actual)
Study completion: 27 Mar 2018 (actual)
First posted: 30 Jun 2016 (estimated)
Results: Posted 3 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
BLI800 high dose	Experimental	Drug: BLI800BLI800 bowel preparation (high dose)
BLI800 low dose	Experimental	Drug: BLI800BLI800 bowel preparation (low dose)
PEG-ELS	Active comparator	Drug: PEG-ELSPEG based bowel preparation

Who may qualify

Ages: 12 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (14 listed)

Male or female between the ages of 12 to 16 (inclusive)
Undergoing colonoscopy for routinely accepted indications, including (but not limited to):
If female, and of child-bearing potential, subject must use an acceptable form of birth control or remain abstinent for the duration of the study.
Negative pregnancy test at screening, if applicable
In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.

Key exclusion criteria (19 listed)

Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.
Subjects who had previous significant gastrointestinal surgeries.
Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.
Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, uncorrected dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PEG-ELSpolyethylene glycol based bowel preparation	Drug	PEG-ELS
BLI800BLI800 bowel preparation	Drug	BLI800 high dose, BLI800 low dose

Primary outcome

Number and Percentage of Subjects With Successful Bowel Cleansing
Time frame: 2 days
Cleansing is rated by a blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)

Results and safety

Results posted to the registry on 3 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BLI800 High Dose	31	26
BLI800 Low Dose	28	26
PEG-ELS	32	31

Primary outcome: Number and Percentage of Subjects With Successful Bowel Cleansing

Time frame: 2 days. Count of participants. Unit: Participants

Measure	BLI800 High Dose n = 31	BLI800 Low Dose n = 27	PEG-ELS n = 32
Value	25	22	19

BLI800 Low Dose vs PEG-ELS: p = 0.003, Cochran-Mantel-Haenszel
BLI800 High Dose vs PEG-ELS: p = 0.003, Cochran-Mantel-Haenszel
BLI800 Low Dose vs PEG-ELS: p = 0.046, Cochran-Mantel-Haenszel

Population analysed: Efficacy population

Adverse events

Time frame: 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BLI800 High Dose	0 of 31 (0%)	29 of 31 (93.5%)	0 of 31
BLI800 Low Dose	0 of 28 (0%)	26 of 28 (92.9%)	0 of 28
PEG-ELS	1 of 32 (3.1%)	29 of 32 (90.6%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John McGowan study director

Braintree Laboratories, Inc.

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PEG-ELS and BLI800 in people with Colonoscopy, run by Braintree Laboratories at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Percentage of Subjects With Successful Bowel Cleansing (time frame: 2 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02819323.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.