ColonoscopyPhase 3NCT00856843
BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
A Phase 3 study testing BLI800 and Polyethylene glycol 3350 based bowel preparation in people with Colonoscopy, run by Braintree Laboratories at 5 sites in United States.
Trial summary
To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- BLI800 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
- 136 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2009to May 2009
- 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.
- 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
- 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 who had previous gastrointestinal surgeries.
- Subjects with known or suspected electrolyte abnormalities such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
- Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects undergoing colonoscopy for foreign body removal and decompression.
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- 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Long Island GI Research Group
Great Neck, New York, 11023
Indiana University Medical Center
Indianapolis, Indiana, 46202
Jupiter Research
Jupiter, Florida, 33458
Miami Research Associates
Miami, Florida, 33143
University of South Alabama
Mobile, Alabama, 36693
About this study
To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.
- Conditions
- Colonoscopy
- Being tested
- BLI800, Polyethylene glycol 3350 based bowel preparation
- Keywords
- colonoscopy, bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI800Drug
Solution for oral administration prior to colonoscopy
Polyethylene glycol 3350 based bowel preparationDrug
Solution for oral administration prior to colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene glycol 3350 based bowel preparation | Active comparator | Polyethylene glycol 3350 based bowel preparation Receives: Drug: Polyethylene glycol 3350 based bowel preparation |
| BLI800 | Experimental | BLI800 Receives: Drug: BLI800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.
Measured: 2 days
Secondary outcomes (13)
Assessment of Residual Stool - Cecum
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Measured: 2 days
Assessment of Residual Stool - Ascending Colon
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Measured: 2 days
Assessment of Residual Stool - Transverse Colon
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Measured: 2 days
Assessment of Residual Stool - Descending Colon
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Measured: 2 days
Assessment of Residual Stool - Sigmoid Colon/Rectum
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Measured: 2 days
Assessment of Residual Fluid - Cecum
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Measured: 2 days
Assessment of Residual Fluid - Ascending Colon
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Measured: 2 days
Assessment of Residual Fluid - Transverse Colon
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Measured: 2 days
Assessment of Residual Fluid - Descending Colon
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Measured: 2 days
Assessment of Residual Fluid - Sigmoid Colon/Rectum
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Measured: 2 days
Subject Symptom Scores
Expected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing).
Measured: 2 days
Mean Change in Serum Chemistry (mg/dL)
Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.
Measured: up to 15 days
Mean Change in Serum Chemistry (mEq/L)
Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.
Measured: up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John McGowan, MPH, Study director, Braintree Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856843
- Sponsor's protocol ID
- BLI800-303
- Status last verified
- Oct 2010
- First submitted
- 5 Mar 2009
- Last updated
- 10 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010 Aug;72(2):328-36. doi: 10.1016/j.gie.2010.03.1054. Epub 2010 Jun 19.
PubMed 20646695
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
- ClinicalTrials.gov ID
- NCT00856843
- Acronym / sponsor ID
- BLI800-303
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, bowel preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Posted 10 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyethylene glycol 3350 based bowel preparation | Active comparator | Drug: Polyethylene glycol 3350 based bowel preparationPolyethylene glycol 3350 based bowel preparation |
| BLI800 | Experimental | Drug: BLI800BLI800 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
- 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
- Negative urine pregnancy test at screening, if applicable
Key exclusion criteria (11 listed)
- Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
- Subjects who had previous gastrointestinal surgeries.
- Subjects with known or suspected electrolyte abnormalities such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
- Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
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 |
|---|---|---|
| BLI800Solution for oral administration prior to colonoscopy | Drug | BLI800 |
| Polyethylene glycol 3350 based bowel preparationSolution for oral administration prior to colonoscopy | Drug | Polyethylene glycol 3350 based bowel preparation |
Primary outcome
Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
Time frame: 2 days
Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.
13 secondary outcomes
Assessment of Residual Stool - Cecum
Time frame: 2 days
Assessment of Residual Stool - Ascending Colon
Time frame: 2 days
Assessment of Residual Stool - Transverse Colon
Time frame: 2 days
Assessment of Residual Stool - Descending Colon
Time frame: 2 days
Assessment of Residual Stool - Sigmoid Colon/Rectum
Time frame: 2 days
Assessment of Residual Fluid - Cecum
Time frame: 2 days
Assessment of Residual Fluid - Ascending Colon
Time frame: 2 days
Assessment of Residual Fluid - Transverse Colon
Time frame: 2 days
Assessment of Residual Fluid - Descending Colon
Time frame: 2 days
Assessment of Residual Fluid - Sigmoid Colon/Rectum
Time frame: 2 days
Subject Symptom Scores
Time frame: 2 days
Mean Change in Serum Chemistry (mg/dL)
Time frame: up to 15 days
Mean Change in Serum Chemistry (mEq/L)
Time frame: up to 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20646695Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010 Aug;72(2):328-36. doi: 10.1016/j.gie.2010.03.1054. Epub 2010 Jun 19.
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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.
5 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 BLI800 and Polyethylene glycol 3350 based bowel preparation in people with Colonoscopy, run by Braintree Laboratories at 5 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 6 inclusion and 11 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 10 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 10 Nov 2010). 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: Percentage of Patients With Successful Preparations Based on a 4 Point Scale (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 NCT00856843, 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 10 Nov 2010.