ColonoscopyPhase 3NCT03404401

A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy

A Phase 3 study testing BLI4700 and Polyethylene glycol bowel preparation in people with Colonoscopy, run by Braintree Laboratories at 23 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 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Colonoscopy
What is being tested?: BLI4700 and Polyethylene glycol bowel preparation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 620 participants
Where: 23 sitesUnited States
Study dates: 11 Jan 2018to 10 Jul 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 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 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 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. NSAID use for occasional pain is not exclusionary.
Subjects with uncontrolled hypertension (systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg).

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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.
Subjects allergic to any preparation component.
Subjects using drugs of abuse, including abused prescription medications.
Subjects who are withdrawing from alcohol or benzodiazepines.
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.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Braintree Research Site 209
Anaheim, California, 92801
Braintree Research Site 224
Atlanta, Georgia, 30342
Braintree Research Site 219
Chula Vista, California, 91910
Braintree Research Site 214
Cincinnati, Ohio, 45219
Braintree Research Site 216
Columbia, South Carolina, 29203
Braintree Research Site 215
Decatur, Georgia, 30033
Braintree Research Site 218
Flowood, Mississippi, 39232
Braintree Research Site 202
Franklin, Tennessee, 37067
Braintree Research Site 210
Great Neck, New York, 11023
Braintree Research Site 207
Hagerstown, Maryland, 21742
Braintree Research Site 221
Inverness, Florida, 34452
Braintree Research Site 203
Jackson, Tennessee, 38305
Braintree Research Site 222
Jacksonville, Florida, 32216
Braintree Research Site 223
Lake Charles, Louisiana, 70601
Braintree Research Site 206
Los Angeles, California, 90045
Braintree Research Site 208
Milwaukee, Wisconsin, 53215
Braintree Research Site 212
Mobile, Alabama, 36688
Braintree Research Site 211
Monroe, Louisiana, 71201
Braintree Research Site 217
Ogden, Utah, 84405
Braintree Research Site 201
Palm Harbor, Florida, 34684
Braintree Research Site 213
Portland, Oregon, 97210
Braintree Research Site 220
San Diego, California, 92114
Braintree Research Site 204
Tucson, Arizona, 85712

Other trials in United States

About this study

Official title: BLI4700-301: A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Conditions: Colonoscopy
Being tested: BLI4700, Polyethylene glycol bowel preparation

What participants receive

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

BLI4700Drug
Oral bowel preparation
Polyethylene glycol bowel preparationDrug
Oral bowel preparation

Study groups in NCT03404401
Study group	Role	What they receive
BLI4700 Bowel Preparation	Experimental	Not described Receives: Drug: BLI4700
FDA Approved Bowel Preparation	Active comparator	Not described Receives: Drug: Polyethylene glycol bowel preparation

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
% of subjects with successful bowel preparation rated by 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.

11 Jan 201810 Jul 2018

First posted19 Jan 2018
Study start11 Jan 2018
Primary completion10 Jul 2018
Study completion10 Jul 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.
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: 620 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03404401
Sponsor's protocol ID: BLI4700-301
Status last verified: May 2021
First submitted: 12 Jan 2018
Last updated: 8 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 33165006

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 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BLI4700-301: A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
ClinicalTrials.gov ID: NCT03404401
Acronym / sponsor ID: BLI4700-301
Conditions: Colonoscopy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 620 participants (actual)
Lead sponsor: Braintree LaboratoriesIndustry (pharma, biotech, devices)
Study start: 11 Jan 2018 (actual)
Primary completion: 10 Jul 2018 (actual)
Study completion: 10 Jul 2018 (actual)
First posted: 19 Jan 2018 (actual)
Results: Posted 8 Sep 2021

Clinical summary

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

Study design

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

Arm	Type	Receives
BLI4700 Bowel Preparation	Experimental	Drug: BLI4700
FDA Approved Bowel Preparation	Active comparator	Drug: Polyethylene glycol 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
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 (21 listed)

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 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. NSAID use for occasional pain is not exclusionary.

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
BLI4700Oral bowel preparation	Drug	BLI4700 Bowel Preparation
Polyethylene glycol bowel preparationOral bowel preparation	Drug	FDA Approved Bowel Preparation

Primary outcome

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

Results and safety

Results posted to the registry on 8 Sep 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
BLI4700 Bowel Preparation	281	263
FDA Approved Bowel Preparation	271	252

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

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

Measure	BLI4700 Bowel Preparation n = 278	FDA Approved Bowel Preparation n = 270
Value	257	241

BLI4700 Bowel Preparation vs FDA Approved Bowel Preparation: p <0.001, Cochran-Mantel-Haenszel

Population analysed: Efficacy population

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
BLI4700 Bowel Preparation	0 of 281 (0%)	1 of 281 (0.4%)	0 of 281
FDA Approved Bowel Preparation	2 of 271 (0.7%)	4 of 271 (1.5%)	0 of 271

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33165006Di 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.
Individual participant dataSharing planned: Undecided

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RecruitingObservational study
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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.

23 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 BLI4700 and Polyethylene glycol bowel preparation in people with Colonoscopy, run by Braintree Laboratories at 23 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 21 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 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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 8 Sep 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: 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 NCT03404401, 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 8 Sep 2021.