ColonoscopyPhase 2NCT03103581

BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

A Phase 2 study testing BLI4700 in people with Colonoscopy, run by Braintree Laboratories at 2 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 BLI4700 as a bowel preparation prior to colonoscopy in adult patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colonoscopy
What is being tested?: BLI4700
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 2 sitesUnited States
Study dates: 16 Feb 2017to 10 Apr 2017
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Primary Inclusion Criteria:

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
At least 18 years of age
If female, and of child-bearing potential, is using an acceptable form of birth control.
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

Primary Exclusion Criteria:

Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
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 a prior history of renal, liver or cardiac insufficiency
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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Braintree Research Site 1
Anaheim, California, 92801
Braintree Research Site 2
Bastrop, Louisiana, 71220

Other trials in United States

About this study

Official title: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.

Conditions: Colonoscopy
Being tested: BLI4700

What participants receive

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

BLI4700Drug
BLI4700 Bowel Preparation (Investigational Regimen)

Study groups in NCT03103581
Study group	Role	What they receive
BLI4700	Experimental	BLI4700 Bowel Preparation (Investigational Regimen) Receives: Drug: BLI4700

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: Day of colonoscopy

Timeline

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

16 Feb 201710 Apr 2017

First posted6 Apr 2017
Study start16 Feb 2017
Primary completion10 Apr 2017
Study completion10 Apr 2017

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03103581
Sponsor's protocol ID: BLI4700-202
Status last verified: Oct 2023
First submitted: 31 Mar 2017
Last updated: 15 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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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All Colonoscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
ClinicalTrials.gov ID: NCT03103581
Acronym / sponsor ID: BLI4700-202
Conditions: Colonoscopy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Braintree LaboratoriesIndustry (pharma, biotech, devices)
Study start: 16 Feb 2017 (actual)
Primary completion: 10 Apr 2017 (actual)
Study completion: 10 Apr 2017 (actual)
First posted: 6 Apr 2017 (actual)
Results: Posted 15 Nov 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 BLI4700 as a bowel preparation prior to colonoscopy in adult patients.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BLI4700	Experimental	Drug: BLI4700BLI4700 Bowel Preparation (Investigational Regimen)

Who may qualify

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

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
BLI4700BLI4700 Bowel Preparation (Investigational Regimen)	Drug	BLI4700

Primary outcome

Proportion of Subjects With Successful Bowel Preparation
Time frame: Day of colonoscopy
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 15 Nov 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
BLI4700	17	15

Primary outcome: Proportion of Subjects With Successful Bowel Preparation

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

Measure	BLI4700 n = 17
Value	15

Population analysed: The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
BLI4700	0 of 17 (0%)	14 of 17 (82.4%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Colonoscopy

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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.

2 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 BLI4700 in people with Colonoscopy, run by Braintree Laboratories at 2 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?

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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 15 Nov 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: 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 NCT03103581.

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 15 Nov 2023.