ColonoscopyPhase 4NCT04214301

An Open-Label Preference Evaluation of BLI800

A Phase 4 study testing BLI800 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 purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Colonoscopy
What is being tested?: BLI800
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesUnited States
Study dates: 24 Sep 2019to 21 Nov 2019
Phase: Phase 4
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

Primary Inclusion Criteria:

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 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 with ongoing severe, acute inflammatory bowel disease
Subjects who had previous significant gastrointestinal surgeries
Subjects with known severe renal, hepatic or cardiac insufficiency
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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Braintree Research Site 2
Bellevue, Washington, 98004
Braintree Research Site 1
Great Neck, New York, 11023

Other trials in United States

About this study

The purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.

Read the detailed description

The objective of this study is to evaluate the patient satisfaction and preference of BLI800 in adult patients undergoing colonoscopy.

Conditions: Colonoscopy
Being tested: BLI800

What participants receive

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

BLI800Drug
BLI800 Bowel Preparation

Study groups in NCT04214301
Study group	Role	What they receive
BLI800	Experimental	BLI800 Receives: Drug: BLI800

What is being measured

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

Ease of Preparation Consumption
Question: How easy or difficult was it to consume the study preparation?
Measured: 2 days

Secondary outcomes (6)

Preparation Compliance
Question: Were you able to consume the entire preparation as instructed?
Measured: 2 days
Rating of Overall Experience
Measured: 2 days
Comparison to Prior Preparation
How did this preparation experience compare to your prior experience?
Measured: 2 days
Willingness to Repeat Preparation
Would you ask your doctor for this preparation again if you need another colonoscopy in the future?
Measured: 2 days
Refuse if Prescribed Again
Would you refuse the same preparation again if it were to be prescribed to you in the future?
Measured: 2 days
Rating of Aftertaste
Measured: 2 days

Timeline

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

24 Sep 201921 Nov 2019

First posted2 Jan 2020
Study start24 Sep 2019
Primary completion21 Nov 2019
Study completion21 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.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04214301
Sponsor's protocol ID: BLI800-491
Status last verified: Sep 2023
First submitted: 27 Dec 2019
Last updated: 23 Oct 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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Patients Aged 50-75 and Requiring Colonoscopy
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Social Software-Based Intelligent Management System for Bowel Preparation
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The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
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All Colonoscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Preference Evaluation of BLI800
ClinicalTrials.gov ID: NCT04214301
Acronym / sponsor ID: BLI800-491
Conditions: Colonoscopy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Braintree LaboratoriesIndustry (pharma, biotech, devices)
Study start: 24 Sep 2019 (actual)
Primary completion: 21 Nov 2019 (actual)
Study completion: 21 Nov 2019 (actual)
First posted: 2 Jan 2020 (actual)
Results: Posted 23 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 evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.

Detailed description

The objective of this study is to evaluate the patient satisfaction and preference of BLI800 in adult patients undergoing colonoscopy.

Study design

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

Arm	Type	Receives
BLI800	Experimental	Drug: BLI800BLI800

Who may qualify

Ages: 18 to 85 years
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
BLI800BLI800 Bowel Preparation	Drug	BLI800

Primary outcome

Ease of Preparation Consumption
Time frame: 2 days
Question: How easy or difficult was it to consume the study preparation?

6 secondary outcomes

Preparation Compliance
Time frame: 2 days
Rating of Overall Experience
Time frame: 2 days
Comparison to Prior Preparation
Time frame: 2 days
Willingness to Repeat Preparation
Time frame: 2 days
Refuse if Prescribed Again
Time frame: 2 days
Rating of Aftertaste
Time frame: 2 days

Results and safety

Results posted to the registry on 23 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
BLI800	40	38

Primary outcome: Ease of Preparation Consumption

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

Measure	BLI800 n = 38
Very Difficult	3
Difficult	5
Tolerable	15
Easy	7
Very Easy	8

6 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
BLI800	0 of 38 (0%)	5 of 38 (13.2%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Colonoscopy

Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
The French Gut-colo
Patients Aged 50-75 and Requiring Colonoscopy
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Active, not recruiting
The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Colorectal Cancer
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma

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 4 study testing BLI800 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 23 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 23 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?

Ease of Preparation Consumption (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 NCT04214301.

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 23 Oct 2023.