ColonoscopyPhase 4NCT00278967
An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
A Phase 4 study testing HalfLytely with Bisacodyl Tablets Bowel Prep Kit and HalfLytely - Reformulation in people with Colonoscopy, run by Braintree Laboratories at 10 sites in United States.
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?
- HalfLytely with Bisacodyl Tablets Bowel Prep Kit and HalfLytely - Reformulation
- Type of treatment
- Pill or oral medicine
- How many people
- 450 participants
- Where
- 10 sitesUnited States
- Study dates
- Feb 2006to Aug 2006
- 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 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 the following routinely accepted indications:
- Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening
- 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 (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, 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
- Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
Show all 12Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Anaheim, California, 92801
Study site
Baton Rouge, Louisiana, 70809
Study site
Bellevue, Washington, 98004
Study site
Germantown, Tennessee, 38138
Study site
Great Neck, New York, 11023
Study site
Jupiter, Florida, 33458
Study site
Laurel, Maryland, 20707
Study site
Miami, Florida, 33173
Study site
Raleigh, North Carolina, 27612
Study site
Spokane, Washington, 99207
About this study
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
Read the detailed description
The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for colonoscopy.
- Conditions
- Colonoscopy
- Being tested
- HalfLytely with Bisacodyl Tablets Bowel Prep Kit, HalfLytely - Reformulation
- Keywords
- colonoscopy, preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HalfLytely with Bisacodyl Tablets Bowel Prep KitDrug
HalfLytely - ReformulationDrug
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startFeb 2006
- Study completionAug 2006
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
- 450 participants
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Goldstein, M.D., Principal investigator, Long Island GI Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278967
- Sponsor's protocol ID
- F38-26
- Status last verified
- Oct 2006
- First submitted
- 13 Jan 2006
- Last updated
- 19 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
- ClinicalTrials.gov ID
- NCT00278967
- Acronym / sponsor ID
- F38-26
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Study completion
- Aug 2006
- First posted
- 19 Jan 2006 (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.
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
Detailed description
The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female outpatients who are undergoing colonoscopy for the following routinely accepted indications:
- Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening
- 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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
Key exclusion criteria (12 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
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 with Bisacodyl Tablets Bowel Prep Kit | Drug | – |
| HalfLytely - Reformulation | Drug | – |
Primary outcome
Efficacy - preparation quality using a 4-point scale
1 secondary outcome
Safety - patient-reported preparation related side-effects
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 19 Oct 2006.
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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.
Michael Goldstein, M.D. principal investigator
Long Island GI Research Group
10 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 with Bisacodyl Tablets Bowel Prep Kit and HalfLytely - Reformulation in people with Colonoscopy, run by Braintree Laboratories at 10 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 7 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 19 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 19 Oct 2006.