ColonoscopyPhase 4NCT00857272

F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

A Phase 4 study testing PEG electrolyte lavage solution + bisacodyl - reformulation and PEG electrolyte lavage solution + bisacodyl in people with Colonoscopy, run by Braintree Laboratories at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy 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?: PEG electrolyte lavage solution + bisacodyl - reformulation and PEG electrolyte lavage solution + bisacodyl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 308 participants
Where: 6 sitesUnited States
Study dates: Feb 2009to May 2009
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 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 indications:
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, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
Subjects with impaired consciousness that predisposes them to pulmonary aspiration
Subjects who are undergoing colonoscopy for foreign body removal and decompression
Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics
Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia

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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 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 clinical, surgical, drug, or device study within the past 30 days

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Advanced Clinical Research Institute
Anaheim, California, 92801
Franklin Gastroenterology
Franklin, Tennessee, 37067
Maryland Digestive Disease Research
Laurel, Maryland, 20707
United Medical Research
New Smyrna Beach, Florida, 32168
Advanced Clinical Research Institute
Orange, California, 92869
Medical Associates Research Group
San Diego, California, 92123

Other trials in United States

About this study

To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.

Conditions: Colonoscopy
Being tested: PEG electrolyte lavage solution + bisacodyl - reformulation, PEG electrolyte lavage solution + bisacodyl
Keywords: colonoscopy, bowel preparation

What participants receive

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

PEG electrolyte lavage solution + bisacodyl - reformulationDrug
multi dose formulation (tablet/solution) for oral administration prior to colonoscopy
PEG electrolyte lavage solution + bisacodylDrug
multi dose preparation (tablet/solution) for oral administration prior to colonoscopy

Study groups in NCT00857272
Study group	Role	What they receive
HalfLytely with 10mg bisacodyl	Active comparator	Active control Receives: Drug: PEG electrolyte lavage solution + bisacodyl
HalfLytely with 5mg bisacodyl	Experimental	Investigational dose Receives: Drug: PEG electrolyte lavage solution + bisacodyl - reformulation

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
Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = "excellent" (no more than small bits of adherent feces/fluid); 3 = "good" (small amounts of feces or fluid not interfering with the exam); 2 = "fair" (enough feces or fluid to prevent a completely reliable exam); 1 = "poor" (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a "success" and grades of 2 or 1 were considered a "failure".
Measured: during colonoscopy

Timeline

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

Feb 2009May 2009

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.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 308 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00857272
Sponsor's protocol ID: F38-27
Status last verified: Sep 2010
First submitted: 5 Mar 2009
Last updated: 5 Oct 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
ClinicalTrials.gov ID: NCT00857272
Acronym / sponsor ID: F38-27
Conditions: Colonoscopy
Keywords: colonoscopy, bowel preparation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 308 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 28 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy 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
HalfLytely with 10mg bisacodyl	Active comparator	Drug: PEG electrolyte lavage solution + bisacodylActive control
HalfLytely with 5mg bisacodyl	Experimental	Drug: PEG electrolyte lavage solution + bisacodyl - reformulationInvestigational dose

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 indications:
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, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
Subjects with impaired consciousness that predisposes them to pulmonary aspiration
Subjects who are undergoing colonoscopy for foreign body removal and decompression
Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics

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 electrolyte lavage solution + bisacodyl - reformulationmulti dose formulation (tablet/solution) for oral administration prior to colonoscopy	Drug	HalfLytely with 5mg bisacodyl
PEG electrolyte lavage solution + bisacodylmulti dose preparation (tablet/solution) for oral administration prior to colonoscopy	Drug	HalfLytely with 10mg bisacodyl

Primary outcome

Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale
Time frame: during colonoscopy
Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = "excellent" (no more than small bits of adherent feces/fluid); 3 = "good" (small amounts of feces or fluid not interfering with the exam); 2 = "fair" (enough feces or fluid to prevent a completely reliable exam); 1 = "poor" (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a "success" and grades of 2 or 1 were considered a "failure".

Results and safety

Results posted to the registry on 28 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HalfLytely With 5mg Bisacodyl	154	145
HalfLytely With 10mg Bisacodyl	154	145

Primary outcome: Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale

Time frame: during colonoscopy. Number (95% Confidence Interval). Unit: percent of participants

Measure	HalfLytely With 5mg Bisacodyl n = 147	HalfLytely With 10mg Bisacodyl n = 146
Value	77.6 (69.9 to 84.0)	80.1 (72.7 to 86.3)

HalfLytely With 5mg Bisacodyl vs HalfLytely With 10mg Bisacodyl: Difference in success rates: -2.5 (95% CI -11.9 to 6.8), p = 0.005, Chi-squared

Population analysed: The analysis population consists of patients that were randomized and took any portion of the study preparation and who did not discontinue prior to colonoscopy due to a reason of safety or efficacy.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HalfLytely With 5mg Bisacodyl	0 of 154 (0%)	117 of 154 (76%)	Not reported
HalfLytely With 10mg Bisacodyl	1 of 154 (0.6%)	129 of 154 (83.8%)	Not reported

Limitations and caveats (from the sponsor): Total number of patients experiencing a non-serious adverse event is based on all adverse events, not just those events above the reporting threshold of 3%

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2010.
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 McGowan, MPH study director

Braintree Laboratories, Inc.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 28 Sep 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: during colonoscopy). 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 NCT00857272.

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 5 Oct 2010.