ColonoscopyPhase 3NCT00164164
HalfLytely Bowel Prep System for Colonoscopy
A Phase 3 study testing HalfLytely and NuLytely in people with Colonoscopy, run by Braintree Laboratories at 2 sites in United States.
Trial summary
The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy. 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 and NuLytely
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 1999to Jun 2000
- Phase
- Phase 3
- 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 at least 18 years of age
- All women of childbearing potential (this includes women who are single and women whose sexual partners have been vasectomized) are required to use medically acceptable contraception during their participation in the study.
- In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent
- Patient is undergoing a colonoscopy for a routinely accepted indication
Who cannot join
- ileus
- possible intestinal obstruction or perforation
- prior alimentary tract surgery
- significant gastroparesis or gastric outlet obstruction
- impaired consciousness that predisposes a patient to pulmonary aspiration
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Braintree, Massachusetts, 02184
Study site
San Antonio, Texas, 78284
About this study
The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.
- Conditions
- Colonoscopy
- Being tested
- HalfLytely, NuLytely
- Keywords
- colonoscopy preparation, prep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HalfLytelyDrug
NuLytelyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Bowel preparation success: preparation rated as "good" or "excellent" by the blinded examiner
Secondary outcomes (1)
Safety - Review of preparation symptoms, adverse events, and laboratory testing
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 startAug 1999
- Primary completionJun 2000
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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charles Brady, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164164
- Sponsor's protocol ID
- F38-20
- 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
- HalfLytely Bowel Prep System for Colonoscopy
- ClinicalTrials.gov ID
- NCT00164164
- Acronym / sponsor ID
- F38-20
- Conditions
- Colonoscopy
- Keywords
- colonoscopy preparation, prep
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Aug 1999
- Primary completion
- Jun 2000 (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.
The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female outpatients at least 18 years of age
- All women of childbearing potential (this includes women who are single and women whose sexual partners have been vasectomized) are required to use medically acceptable contraception during their participation in the study.
- In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent
- Patient is undergoing a colonoscopy for a routinely accepted indication
Key exclusion criteria (5 listed)
- ileus
- possible intestinal obstruction or perforation
- prior alimentary tract surgery
- significant gastroparesis or gastric outlet obstruction
- impaired consciousness that predisposes a patient to pulmonary aspiration
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 | – |
| NuLytely | Drug | – |
Primary outcome
Efficacy - Bowel preparation success: preparation rated as "good" or "excellent" by the blinded examiner
1 secondary outcome
Safety - Review of preparation symptoms, adverse events, and laboratory testing
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.
Charles Brady, MD principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HalfLytely and NuLytely in people with Colonoscopy, run by Braintree Laboratories at 2 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 4 inclusion and 5 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 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 - Bowel preparation success: preparation rated as "good" or "excellent" by the blinded examiner. 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.