ColonoscopyPhase 3NCT01501513
A Safety Study of 3 Different Bowel Cleansing Preparations
A Phase 3 study testing PEG-3350 based bowel preparation, BLI800 approved preparation regimen and BLI800 investigational preparation regimen in people with Colonoscopy and Bowel Preparation, run by Braintree Laboratories at 17 sites in United States.
Trial summary
The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Bowel Preparation, Endoscopy
- What is being tested?
- PEG-3350 based bowel preparation, BLI800 approved preparation regimen and BLI800 investigational preparation regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 541 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2011to 4 Mar 2013
- 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
- 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 significant gastrointestinal surgeries.
- Subjects who have uncontrolled clinically significant pre-existing electrolyte disturbances.
- Subjects with severe liver or renal insufficiency.
- Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
Show all 12Show fewer
- Subjects undergoing colonoscopy for foreign body removal and 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
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302
Carolina Digestive Health Associates
Charlotte, North Carolina, 28262
Charlottesville Medical Research
Charlottesville, Virginia, 22911
ClinSearch
Chattanooga, Tennessee, 37421
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Franklin Gastroenterology
Franklin, Tennessee, 37067
Indiana University
Indianapolis, Indiana, 46202
Gastrointestinal Associates
Jackson, Mississippi, 39202
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Borland-Groover Clinic
Jacksonville, Florida, 32256
University of South Alabama
Mobile, Alabama, 36693
Delta Research Partners
Monroe, Louisiana, 71201
Northwest Gastroenterology
Portland, Oregon, 97210
Wake Research Associates
Raleigh, North Carolina, 27612
Miami Research Associates
South Miami, Florida, 33143
About this study
Official title: A Safety, Tolerance and Efficacy Evaluation of 3 Different Bowel Cleansing Preparations in Adult Subjects, Including the Elderly and Subjects With Hepatic or Renal Insufficiency
The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.
- Conditions
- Colonoscopy, Bowel Preparation, Endoscopy
- Being tested
- PEG-3350 based bowel preparation, BLI800 approved preparation regimen, BLI800 investigational preparation regimen
- Keywords
- colonoscopy, bowel preparation, endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-3350 based bowel preparationDrug
solution for oral administration prior to colonoscopy
BLI800 approved preparation regimenDrug
solution for oral administration prior to colonoscopy
BLI800 investigational preparation regimenDrug
solution for oral administration prior to colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| BLI800 approved preparation regimen | Experimental | BLI800 approved preparation regimen Receives: Drug: BLI800 approved preparation regimen |
| BLI800 investigational preparation regimen | Experimental | BLI800 investigational preparation regimen Receives: Drug: BLI800 investigational preparation regimen |
| PEG-3350 based bowel preparation | Active comparator | PEG-3350 based bowel preparation Receives: Drug: PEG-3350 based bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage 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
Secondary outcomes (2)
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy
Count and Percentage of subjects with AEs through Day of Colonoscopy based on 3% threshold. Outcome measure time frame represents the day prior to colonoscopy (when preparation Dose 1 is taken) and the day of colonoscopy (when preparation Dose 2 is taken).
Measured: 2 days
Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7
Count and Percentage of subjects with AEs reported after colonoscopy through follow-up Day 7 based on 3% threshold. Outcome measure time frame represents the period following colonoscopy through follow-up Day 7 (7 days).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startDec 2011
- Primary completion4 Mar 2013
- Study completion4 Mar 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501513
- Sponsor's protocol ID
- BLI800-440
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2011
- Last updated
- 17 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerance and Efficacy Evaluation of 3 Different Bowel Cleansing Preparations in Adult Subjects, Including the Elderly and Subjects With Hepatic or Renal Insufficiency
- ClinicalTrials.gov ID
- NCT01501513
- Acronym / sponsor ID
- BLI800-440
- Conditions
- Colonoscopy, Bowel Preparation, Endoscopy
- Keywords
- colonoscopy, bowel preparation, endoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- 4 Mar 2013 (actual)
- Study completion
- 4 Mar 2013 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Posted 17 Jan 2024
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 compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BLI800 approved preparation regimen | Experimental | Drug: BLI800 approved preparation regimenBLI800 approved preparation regimen |
| BLI800 investigational preparation regimen | Experimental | Drug: BLI800 investigational preparation regimenBLI800 investigational preparation regimen |
| PEG-3350 based bowel preparation | Active comparator | Drug: PEG-3350 based bowel preparationPEG-3350 based bowel preparation |
Who may qualify
- Ages
- 18 years and older
- 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.
- 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
Key exclusion criteria (12 listed)
- 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 who have uncontrolled clinically significant pre-existing electrolyte disturbances.
- Subjects with severe liver or renal insufficiency.
- Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality.
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 |
|---|---|---|
| PEG-3350 based bowel preparationsolution for oral administration prior to colonoscopy | Drug | PEG-3350 based bowel preparation |
| BLI800 approved preparation regimensolution for oral administration prior to colonoscopy | Drug | BLI800 approved preparation regimen |
| BLI800 investigational preparation regimensolution for oral administration prior to colonoscopy | Drug | BLI800 investigational preparation regimen |
Primary outcome
Percentage 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).
2 secondary outcomes
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy
Time frame: 2 days
Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
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.
The record lists no contact. Use the official record to reach the sponsor.
17 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 PEG-3350 based bowel preparation, BLI800 approved preparation regimen and BLI800 investigational preparation regimen in people with Colonoscopy and Bowel Preparation, run by Braintree Laboratories at 17 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 12 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 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 17 Jan 2024). 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?
Percentage 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?
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 17 Jan 2024.