ColonoscopyPhase 3NCT04446312

Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

A Phase 3 study testing Bowel Prep in people with Colonoscopy, run by Braintree Laboratories at 34 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 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Colonoscopy
What is being tested?: Bowel Prep
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 34 sitesUnited States
Study dates: 13 Jul 2020to 5 Feb 2021
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 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.
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

Who cannot join

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.

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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.
Subjects who are withdrawing from alcohol or benzodiazepines.

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

302 Research Site 8
Asheville, North Carolina, 28801
302 Research Site 34
Baton Rouge, Louisiana, 70809
302 Research Site 7
Bellevue, Washington, 98004
302 Research Site 22
Bristol, Connecticut, 06010
302 Research Site 39
Brooklyn, New York, 11235
302 Research Site 32
Cedar Park, Texas, 78613
302 Research Site 6
Charlottesville, Virginia, 22911
302 Research Site 9
Chula Vista, California, 91910
302 Research Site 18
Cincinnati, Ohio, 45219
302 Research Site 4
Fairfax, Virginia, 22031
302 Research Site 17
Fleming Island, Florida, 32003
302 Research Site 37
Great Neck, New York, 11023
302 Research Site 16
Hagerstown, Maryland, 21742
302 Research Site 25
High Point, North Carolina, 27262
302 Research Site 21
Houston, Texas, 77058
302 Research Site 3
Inverness, Florida, 34452
302 Research Site 23
Jackson, Tennessee, 38305
302 Research Site 14
Jacksonville, Florida, 32256
302 Research Site 33
Kingsport, Tennessee, 37660
302 Research Site 10
Little Rock, Arkansas, 72211
302 Research Site 31
Los Angeles, California, 90036
302 Research Site 26
Mandeville, Louisiana, 70471
302 Research Site 28
Miami, Florida, 33134
302 Research Site 29
Miami, Florida, 33155
302 Research Site 30
Miami, Florida, 33155
302 Research Site 36
Monroe, Louisiana, 71201
302 Research Site 11
North Little Rock, Arkansas, 72117
302 Research Site 5
Oak Lawn, Illinois, 60453
302 Research Site 38
Palm Harbor, Florida, 34684
302 Research Site 1
Raleigh, North Carolina, 27612
302 Research Site 35
Southlake, Texas, 76092
302 Research Site 2
Tucson, Arizona, 85712
302 Research Site 27
Webster, Texas, 77598
302 Research Site 13
Wilmington, North Carolina, 28403

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About this study

Official title: A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

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.

Conditions: Colonoscopy
Being tested: Bowel Prep

What participants receive

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

Bowel PrepDrug
Orally ingested liquid bowel preparation

Study groups in NCT04446312
Study group	Role	What they receive
BLI4900	Experimental	Experimental bowel preparation solution for oral ingestion Receives: Drug: Bowel Prep
FDA Approved Control	Active comparator	FDA approved bowel preparation solution for oral ingestion Receives: Drug: Bowel Prep

What is being measured

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

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).
Measured: 2 days

Timeline

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

13 Jul 20205 Feb 2021

First posted24 Jun 2020
Study start13 Jul 2020
Primary completion7 Jan 2021
Study completion5 Feb 2021

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04446312
Sponsor's protocol ID: BLI4900-302
Status last verified: Oct 2023
First submitted: 22 Jun 2020
Last updated: 27 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

Bhandari R, Goldstein M, Mishkin DS, McGowan J, Cleveland MV, Di Palma JA. Comparison of a Novel, Flavor-optimized, Polyethylene Glycol and Sulfate Bowel Preparation With Oral Sulfate Solution in Adults Undergoing Colonoscopy. J Clin Gastroenterol. 2023 Oct 1;57(9):920-927. doi: 10.1097/MCG.0000000000001894.
PubMed 37490604

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 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
ClinicalTrials.gov ID: NCT04446312
Acronym / sponsor ID: BLI4900-302
Conditions: Colonoscopy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: Braintree LaboratoriesIndustry (pharma, biotech, devices)
Study start: 13 Jul 2020 (actual)
Primary completion: 7 Jan 2021 (actual)
Study completion: 5 Feb 2021 (actual)
First posted: 24 Jun 2020 (actual)
Results: Posted 27 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 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BLI4900	Experimental	Drug: Bowel PrepExperimental bowel preparation solution for oral ingestion
FDA Approved Control	Active comparator	Drug: Bowel PrepFDA approved bowel preparation solution for oral ingestion

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.
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

Key exclusion criteria (16 listed)

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.

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
Bowel PrepOrally ingested liquid bowel preparation	Drug	BLI4900, FDA Approved Control

Primary outcome

Proportion of Subjects With Successful Bowel Preparation
Time frame: 2 days
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).

Results and safety

Results posted to the registry on 27 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	250	212
FDA Approved Control	250	206

Primary outcome: Proportion of Subjects With Successful Bowel Preparation

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

Measure	BLI4900 n = 226	FDA Approved Control n = 224
Value	212	211

BLI4900 vs FDA Approved Control: Risk Difference (RD): 0.15 (95% CI -3.97 to 4.27), p <0.001, Mantel Haenszel

Population analysed: Modified intent-to-treat population - this population includes all subjects that took any portion of study preparation and who did not withdraw for a reason other than safety, efficacy or tolerance.

Adverse events

Time frame: 30 days. Other adverse events reported at 1.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BLI4900	0 of 227 (0%)	23 of 227 (10.1%)	0 of 227
FDA Approved Control	2 of 226 (0.9%)	26 of 226 (11.5%)	0 of 226

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37490604Bhandari R, Goldstein M, Mishkin DS, McGowan J, Cleveland MV, Di Palma JA. Comparison of a Novel, Flavor-optimized, Polyethylene Glycol and Sulfate Bowel Preparation With Oral Sulfate Solution in Adults Undergoing Colonoscopy. J Clin Gastroenterol. 2023 Oct 1;57(9):920-927. doi: 10.1097/MCG.0000000000001894.
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 / Sebela Pharmaceuticals

34 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 Bowel Prep in people with Colonoscopy, run by Braintree Laboratories at 34 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 16 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 27 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 34 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 27 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?

Proportion of Subjects With Successful Bowel Preparation (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 NCT04446312, 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 27 Oct 2023.