ColonoscopyPhase 4NCT00425594
A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
A Phase 4 study testing HalfLytely and Bisacodyl Tablets - Formulation 1, HalfLytely and Bisacodyl Tablets - Formulation 2 and NuLYTELY in people with Colonoscopy, run by Braintree Laboratories at 26 sites in United States.
Trial summary
This randomized, parallel, multi-center, single-blind study is designed to compare the safety and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy for a routinely accepted indication. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- HalfLytely and Bisacodyl Tablets - Formulation 1, HalfLytely and Bisacodyl Tablets - Formulation 2 and NuLYTELY
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 26 sitesUnited States
- Study dates
- Jan 2007to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients who are undergoing colonoscopy for a routinely accepted indication, including:
- Evaluation of BE results
- Endosonography
- Blood in stool
- Anemia of unknown etiology
- Abdominal Pain
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- Polypectomy
- Unknown diarrhea or constipation etiology
- Inflammatory bowel disease
- Between 6 and 16 years of age at screening.
- 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, sterilized, abstinent, or vasectomized spouse).
- Negative urine pregnancy test at screening, if applicable
- In the investigator's judgment, parent/guardian 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 impacted at screening
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects who are undergoing colonoscopy for foreign body removal and decompression
- Subjects with known difficulties for swallowing tablets
- Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics.
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- 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
- 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.
- Any condition in parent/guardian associated with poor subject compliance (e.g., substance abuse); inability of parent/guardian to return for scheduled visits with their child.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Study site
Birmingham, Alabama, 35233
Study site
Boston, Massachusetts, 02114
Study site
Buffalo, New York, 14222
Study site
Burlington, Vermont, 05401
Study site
Cleveland, Ohio, 44106
Study site
Columbia, South Carolina, 29203
Study site
Columbus, Ohio, 43205
Study site
Gainesville, Florida, 32610
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Jackson, Mississippi, 39216
Study site
Lancaster, Pennsylvania, 17604
Study site
Las Vegas, Nevada, 89109
Study site
Little Rock, Arkansas, 72202
Study site
Milwaukee, Wisconsin, 53226
Study site
Minneapolis, Minnesota, 55455
Study site
Mobile, Alabama, 36604
Study site
Morristown, New Jersey, 07962
Study site
Omaha, Nebraska, 68198
Study site
Orlando, Florida, 32801
Study site
Park Ridge, Illinois, 60068
Study site
Phoenix, Arizona, 85016
Study site
Salt Lake City, Utah, 84113
Study site
San Francisco, California, 94143
Study site
Temple, Texas, 76508
Study site
Tuscaloosa, Alabama, 35406
About this study
This randomized, parallel, multi-center, single-blind study is designed to compare the safety and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy for a routinely accepted indication.
- Conditions
- Colonoscopy
- Being tested
- HalfLytely and Bisacodyl Tablets - Formulation 1, HalfLytely and Bisacodyl Tablets - Formulation 2, NuLYTELY
- Keywords
- colonoscopy, bowel preparation, prep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HalfLytely and Bisacodyl Tablets - Formulation 1Drug
HalfLytely and Bisacodyl Tablets - Formulation 2Drug
NuLYTELYDrug
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
Secondary outcomes (1)
Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John McGowan, Study director, Braintree Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425594
- Sponsor's protocol ID
- F38-25
- Status last verified
- Dec 2007
- First submitted
- 19 Jan 2007
- Last updated
- 27 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
- ClinicalTrials.gov ID
- NCT00425594
- Acronym / sponsor ID
- F38-25
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, bowel preparation, prep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 23 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, parallel, multi-center, single-blind study is designed to compare the safety and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy for a routinely accepted indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Male or female patients who are undergoing colonoscopy for a routinely accepted indication, including:
- Between 6 and 16 years of age at screening.
- 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, sterilized, abstinent, or vasectomized spouse).
- Negative urine pregnancy test at screening, if applicable
Key exclusion criteria (14 listed)
- Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
- Subjects impacted at screening
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects who are undergoing colonoscopy for foreign body removal and decompression
- Subjects with known difficulties for swallowing tablets
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 |
|---|---|---|
| HalfLytely and Bisacodyl Tablets - Formulation 1 | Drug | – |
| HalfLytely and Bisacodyl Tablets - Formulation 2 | Drug | – |
| NuLYTELY | Drug | – |
Primary outcome
Efficacy - preparation quality using a 4-point scale
1 secondary outcome
Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2007.
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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 study director
Braintree Laboratories, Inc.
26 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 HalfLytely and Bisacodyl Tablets - Formulation 1, HalfLytely and Bisacodyl Tablets - Formulation 2 and NuLYTELY in people with Colonoscopy, run by Braintree Laboratories at 26 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 14 inclusion and 14 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 27 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. 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 27 Dec 2007.