Colon CancerPhase 3NCT00756977
BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
A Phase 3 study testing BLI850 and polyethylene glycol 3350 based bowel preparation in people with Colon Cancer, run by Braintree Laboratories at 12 sites in United States.
Trial summary
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- BLI850 and polyethylene glycol 3350 based bowel preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 12 sitesUnited States
- Study dates
- Aug 2008to Nov 2008
- 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 years and older
- 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, including:
- Evaluation of barium enema results
- GI bleeding
- Anemia of unknown etiology
- Neoplastic disease surveillance
- Abnormal Endosonography
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- Inflammatory bowel disease
- Unknown diarrhea or constipation etiology
- Polypectomy
- Laser therapy
- Routine screening
- At least 18 years of age.
- Otherwise in good health, as determined by physical exam and medical history.
- 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 impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects who are undergoing colonoscopy for foreign body removal or decompression.
- Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
- Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass).
- Subjects who are pregnant or lactating, or intending to become pregnant during the study.
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- Subjects of childbearing potential who refuse a pregnancy test.
- Subjects who are 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
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Southeastern Clinical Research
Chattanooga, Tennessee, 37403
Long Island GI Research Group
Great Neck, New York, 11023
Carolina Digestive Health Associates
Harrisburg, North Carolina, 28075
Jupiter Research
Jupiter, Florida, 33458
Regional Gastroenterology Associates of Lancaster
Lancaster, Pennsylvania, 17604
Maryland Digestive Disease Research
Laurel, Maryland, 20707
Miami Research Associates
Miami, Florida, 33143
University of South Alabama
Mobile, Alabama, 36693
Delta Research Partners
Monroe, Louisiana, 71201
United Medical Research
New Smyrna Beach, Florida, 32168
Wake Research Associates
Raleigh, North Carolina, 27612
Atlanta Gastroenterology Associates
Roswell, Georgia, 30076
About this study
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
- Conditions
- Colon Cancer
- Being tested
- BLI850, polyethylene glycol 3350 based bowel preparation
- Keywords
- Colonoscopy, screening
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI850Drug
multi-dose preparation for oral administration prior to colonoscopy
polyethylene glycol 3350 based bowel preparationDrug
multi-dose preparation for oral administration prior to colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | multi-dose preparation for oral administration prior to colonoscopy Receives: Drug: BLI850 |
| 2 | Active comparator | multi-dose preparation for oral administration prior to colonoscopy Receives: Drug: polyethylene glycol 3350 based bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Preparation Quality Using a 4 Point Scale
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"
Measured: 2-day
Secondary outcomes (10)
Serum Chemistry Results (mg/dL)
Change from Baseline
Measured: 2 days
Hematology Results (%)
Change from Baseline
Measured: 2 days
Serum Chemistry Results (U/L)
Change from Baseline
Measured: 2 days
Serum Chemistry Results (mEq/L)
Change from Baseline
Measured: 2 days
Serum Chemistry Results (g/dL)
Change from Baseline
Measured: 2 days
Serum Chemistry Results (GFR)
Change from Baseline
Measured: 2 days
Hematology Results (1000/MCL)
Change from Baseline
Measured: 2 days
Hematology Results - Hemoglobin
Change from Baseline
Measured: 2 days
Hematology Results - Red Blood Cells
Change from Baseline
Measured: 2 days
Serum Chemistry Results (Osmolality)
Change from Baseline
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2008
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 Colon CancerStudies 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
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John D McGowan, Study director, Braintree Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756977
- Sponsor's protocol ID
- BLI850-301
- Other IDs
- BLI850-301
- Status last verified
- Aug 2013
- First submitted
- 18 Sep 2008
- Last updated
- 15 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT00756977
- Acronym / sponsor ID
- BLI850-301
- Conditions
- Colon Cancer
- Keywords
- Colonoscopy, screening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Posted 9 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BLI850multi-dose preparation for oral administration prior to colonoscopy |
| 2 | Active comparator | Drug: polyethylene glycol 3350 based bowel preparationmulti-dose preparation for oral administration prior to colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:
- At least 18 years of age.
- Otherwise in good health, as determined by physical exam and medical history.
- 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.
Key exclusion criteria (10 listed)
- Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects who are undergoing colonoscopy for foreign body removal or decompression.
- Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
- Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass).
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 |
|---|---|---|
| BLI850multi-dose preparation for oral administration prior to colonoscopy | Drug | 1 |
| polyethylene glycol 3350 based bowel preparationmulti-dose preparation for oral administration prior to colonoscopy | Drug | 2 |
Primary outcome
Efficacy - Preparation Quality Using a 4 Point Scale
Time frame: 2-day
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"
10 secondary outcomes
Serum Chemistry Results (mg/dL)
Time frame: 2 days
Hematology Results (%)
Time frame: 2 days
Serum Chemistry Results (U/L)
Time frame: 2 days
Serum Chemistry Results (mEq/L)
Time frame: 2 days
Serum Chemistry Results (g/dL)
Time frame: 2 days
Serum Chemistry Results (GFR)
Time frame: 2 days
Hematology Results (1000/MCL)
Time frame: 2 days
Hematology Results - Hemoglobin
Time frame: 2 days
Hematology Results - Red Blood Cells
Time frame: 2 days
Serum Chemistry Results (Osmolality)
Time frame: 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 D McGowan study director
Braintree Laboratories
12 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 BLI850 and polyethylene glycol 3350 based bowel preparation in people with Colon Cancer, run by Braintree Laboratories at 12 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 16 inclusion and 10 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 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 9 Aug 2013). 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?
Efficacy - Preparation Quality Using a 4 Point Scale (time frame: 2-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2013.