ColonoscopyPhase 2NCT03328507

A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

A Phase 2 study testing BLI4900 in people with Colonoscopy, run by Braintree Laboratories at 4 sites in United States.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Colonoscopy
What is being tested?: BLI4900
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 4 sitesUnited States
Study dates: 9 Nov 2017to 12 Nov 2019
Phase: Phase 2
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 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
18 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.

Who cannot join

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).

Show all 17Show fewer

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.
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

4 sites in 1 country.

United States4 sites

Braintree Research Site 1
Anaheim, California, 92801
Braintree Research Site 3
Chula Vista, California, 91910
Braintree Clinical Research Site 2
Ogden, Utah, 84405
Braintree Research Site 4
San Diego, California, 92114

Other trials in United States

About this study

The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel preparation prior to colonoscopy in adult patients.

Conditions: Colonoscopy
Being tested: BLI4900, PEG Control

What participants receive

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

BLI4900Drug
BLI4900 Bowel Preparation
PEG ControlDrug
Polyethylene glycol-based bowel preparation

Study groups in NCT03328507
Study group	Role	What they receive
BLI4900	Experimental	BLI4900 Bowel Preparation Receives: Drug: BLI4900
PEG Control	Active comparator	Polyethylene glycol-based bowel preparation Receives: Drug: PEG Control

What is being measured

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

% 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)
Measured: Day of colonoscopy

Timeline

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

9 Nov 201712 Nov 2019

First posted1 Nov 2017
Study start9 Nov 2017
Primary completion12 Nov 2019
Study completion12 Nov 2019

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.
Publications (1)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03328507
Sponsor's protocol ID: BLI4900-201
Status last verified: Sep 2023
First submitted: 30 Oct 2017
Last updated: 24 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38082231

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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All Colonoscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects
ClinicalTrials.gov ID: NCT03328507
Acronym / sponsor ID: BLI4900-201
Conditions: Colonoscopy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Braintree LaboratoriesIndustry (pharma, biotech, devices)
Study start: 9 Nov 2017 (actual)
Primary completion: 12 Nov 2019 (actual)
Study completion: 12 Nov 2019 (actual)
First posted: 1 Nov 2017 (actual)
Results: Posted 24 Oct 2023

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 evaluate the safety and efficacy of BLI4900 as a bowel preparation prior to colonoscopy in adult patients.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BLI4900	Experimental	Drug: BLI4900BLI4900 Bowel Preparation
PEG Control	Active comparator	Drug: PEG ControlPolyethylene glycol-based bowel preparation

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
18 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.

Key exclusion criteria (17 listed)

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).

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
BLI4900BLI4900 Bowel Preparation	Drug	BLI4900
PEG ControlPolyethylene glycol-based bowel preparation	Drug	PEG Control

Primary outcome

% of Subjects With Successful Bowel Preparation
Time frame: Day of colonoscopy
% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)

Results and safety

Results posted to the registry on 24 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BLI4900-3	21	21
BLI4900-5	40	40
BLI4900-6	41	40
PEG-SD	19	19

Primary outcome: % of Subjects With Successful Bowel Preparation

Time frame: Day of colonoscopy. Count of participants. Unit: Participants

Measure	BLI4900-3 n = 21	BLI4900-5 n = 40	BLI4900-6 n = 40	PEG-SD n = 19
Value	17	37	37	16

Adverse events

Time frame: 2 days. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BLI4900-3	0 of 21 (0%)	13 of 21 (61.9%)	0 of 21
BLI4900-5	0 of 40 (0%)	31 of 40 (77.5%)	0 of 40
BLI4900-6	0 of 41 (0%)	13 of 41 (31.7%)	0 of 41
PEG-SD	1 of 19 (5.3%)	14 of 19 (73.7%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38082231Wiener 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.
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, MPH study director

Braintree Laboratories, Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BLI4900 in people with Colonoscopy, run by Braintree Laboratories at 4 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 5 inclusion and 17 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 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 24 Oct 2023). 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?

% of Subjects With Successful Bowel Preparation (time frame: Day of colonoscopy). 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 NCT03328507, which also lists 1 linked publication.

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 24 Oct 2023.