Colon CleansingPhase 4NCT01427296
Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
A Phase 4 study testing Polyethylene glycol and Oral sodium phosphate solution in people with Colon Cleansing, run by Bausch Health Americas, Inc. at 18 sites in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colon Cleansing
- What is being tested?
- Polyethylene glycol and Oral sodium phosphate solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,154 participants
- Where
- 18 sitesUnited States
- Study dates
- 16 Sep 2011to 9 Dec 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 70 years of age, inclusive
- Scheduled for colonoscopy within 21 days of the screening visit
- Able to swallow tablets the size of a multivitamin without difficulty
Who cannot join
- History of biopsy-proven acute phosphate nephropathy
- Known allergy or hypersensitivity to treatment arms
- History of gastric stapling or bypass procedure or history of gastric retention
- History of any other sodium phosphate preparation within 6 months prior to colonoscopy
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Bellevue, Washington
Study site
Bristol, Connecticut
Study site
Chesapeake, Virginia
Study site
Cincinnati, Ohio
Study site
Fayetteville, North Carolina
Study site
Great Neck, New York
Study site
Hagerstown, Maryland
Study site
High Point, North Carolina
Study site
Macon, Georgia
Study site
Mentor, Ohio
Study site
Mexico, Missouri
Study site
New York, New York
Study site
Plano, Texas
Study site
Raleigh, North Carolina
Study site
San Carlos, California
Study site
Suwanee, Georgia
Study site
Vineland, New Jersey
Study site
Wyoming, Michigan
About this study
Official title: A Phase 4, Randomized, Active Comparator, Open-Label, Multicenter Study to Assess the Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.
- Conditions
- Colon Cleansing
- Being tested
- Polyethylene glycol, Oral sodium phosphate solution
- Keywords
- Colon Cleansing, Bowel Prep, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycolDrug
HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
Oral sodium phosphate solutionDrug
OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
| Study group | Role | What they receive |
|---|---|---|
| OsmoPrep Tablets | Active comparator | Not described Receives: Drug: Oral sodium phosphate solution |
| HalfLytely and Bisacodyl Tablet | Active comparator | Not described Receives: Drug: Polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study start16 Sep 2011
- Primary completion11 Mar 2014
- Study completion9 Dec 2014
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 CleansingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427296
- Sponsor's protocol ID
- OSBP4011
- Status last verified
- Dec 2017
- First submitted
- 30 Aug 2011
- Last updated
- 18 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized, Active Comparator, Open-Label, Multicenter Study to Assess the Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
- ClinicalTrials.gov ID
- NCT01427296
- Acronym / sponsor ID
- OSBP4011
- Conditions
- Colon Cleansing
- Keywords
- Colon Cleansing, Bowel Prep, Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,154 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2011 (actual)
- Primary completion
- 11 Mar 2014 (actual)
- Study completion
- 9 Dec 2014 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Posted 18 Jan 2018
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 compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OsmoPrep Tablets | Active comparator | Drug: Oral sodium phosphate solution |
| HalfLytely and Bisacodyl Tablet | Active comparator | Drug: Polyethylene glycol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18 and 70 years of age, inclusive
- Scheduled for colonoscopy within 21 days of the screening visit
- Able to swallow tablets the size of a multivitamin without difficulty
Key exclusion criteria (4 listed)
- History of biopsy-proven acute phosphate nephropathy
- Known allergy or hypersensitivity to treatment arms
- History of gastric stapling or bypass procedure or history of gastric retention
- History of any other sodium phosphate preparation within 6 months prior to colonoscopy
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 |
|---|---|---|
| Polyethylene glycolHalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L | Drug | HalfLytely and Bisacodyl Tablet |
| Oral sodium phosphate solutionOsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L | Drug | OsmoPrep Tablets |
Primary outcome
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 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 Polyethylene glycol and Oral sodium phosphate solution in people with Colon Cleansing, run by Bausch Health Americas, Inc. at 18 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 3 inclusion and 4 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 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 18 Jan 2018). 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?
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. (time frame: 6 months). 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 18 Jan 2018.