ColonoscopyPhase 4NCT00164177
Evaluation Of The Efficacy Of HalfLYTELY For Bowel Cleansing Before Virtual Colonoscopy and Conventional Colonoscopy.
A Phase 4 study testing HalfLytely in people with Colonoscopy, run by Braintree Laboratories at 1 site in United States.
Trial summary
To evaluate the efficacy of standard HalfLYTELY® as a bowel cleansing preparation for adult patients undergoing virtual colonoscopy (VC). 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
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Dec 2004
- 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
- Adult, Older adult
Who may be able to join
- Male or female outpatients who are undergoing colonoscopy for routinely accepted indications, Evaluation of BE results, GI bleeding, Anemia of unknown etiology, Neoplastic disease surveillance, Endosonography, Inflammatory bowel disease (except as noted below), Unknown diarrhea etiology, Prior Polypectomy, Laser therapy, Foreign body removal and decompression (except as noted below).
- 18 years of age or older.
- 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, or vasectomized spouse)
- Subject has read and signed the written informed consent document prior to study participation
Who cannot join
- Subjects with known or suspected bowel perforation or obstruction, inflammatory bowel disease, ileus, acute alimentary tract surgery, significant gastroparesis or gastric outlet obstruction, appendicitis, gastric retention, toxic colitis, toxic megacolon or rectal bleeding.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects with uncontrolled cardiovascular disease
- 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.
- Subjects who are pregnant or lactating.
- Subjects who are allergic to Polyethyleneglycol.
- Subjects receiving non-study laxatives, antacids and prokinetic agents during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Preliminary Evaluation Of The Efficacy Of HalfLYTELY® For Bowel Cleansing Before Virtual Colonoscopy (VC) and Conventional Colonoscopy (CC).
To evaluate the efficacy of standard HalfLYTELY® as a bowel cleansing preparation for adult patients undergoing virtual colonoscopy (VC).
- Conditions
- Colonoscopy
- Being tested
- HalfLytely
- Keywords
- virtual colonoscopy, colonoscopy preparation, bowel prep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HalfLytelyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.
Secondary outcomes (1)
Incidence of adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2004
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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- H. Paul Hatten, Jr., MD, Principal investigator, Indian River Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164177
- Sponsor's protocol ID
- F38-VC-002
- Status last verified
- Feb 2013
- First submitted
- 9 Sep 2005
- Last updated
- 7 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Evaluation Of The Efficacy Of HalfLYTELY® For Bowel Cleansing Before Virtual Colonoscopy (VC) and Conventional Colonoscopy (CC).
- ClinicalTrials.gov ID
- NCT00164177
- Acronym / sponsor ID
- F38-VC-002
- Conditions
- Colonoscopy
- Keywords
- virtual colonoscopy, colonoscopy preparation, bowel prep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Dec 2004 (actual)
- First posted
- 14 Sep 2005 (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 evaluate the efficacy of standard HalfLYTELY® as a bowel cleansing preparation for adult patients undergoing virtual colonoscopy (VC).
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female outpatients who are undergoing colonoscopy for routinely accepted indications, Evaluation of BE results, GI bleeding, Anemia of unknown etiology, Neoplastic disease surveillance, Endosonography, Inflammatory bowel disease (except as noted below), Unknown diarrhea etiology, Prior Polypectomy, Laser therapy, Foreign body removal and decompression (except as noted below).
- 18 years of age or older.
- 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, or vasectomized spouse)
- Subject has read and signed the written informed consent document prior to study participation
Key exclusion criteria (8 listed)
- Subjects with known or suspected bowel perforation or obstruction, inflammatory bowel disease, ileus, acute alimentary tract surgery, significant gastroparesis or gastric outlet obstruction, appendicitis, gastric retention, toxic colitis, toxic megacolon or rectal bleeding.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects with uncontrolled cardiovascular disease
- 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.
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 | Drug | – |
Primary outcome
Efficacy of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.
1 secondary outcome
Incidence of adverse events.
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 7 Feb 2013.
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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.
H. Paul Hatten, Jr., MD principal investigator
Indian River Radiology
1 site 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 in people with Colonoscopy, run by Braintree Laboratories at 1 site 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 8 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 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.. 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 7 Feb 2013.