ColonoscopyPhase 3NCT00164151
A Comparison of the Efficacy and Safety of HalfLytely Vs Visicol Prior To Colonoscopy.
A Phase 3 study testing HalfLytely and Visicol in people with Colonoscopy, run by Braintree Laboratories at 1 site in United States.
Trial summary
The objective of this study is to determine the efficacy and safety of HalfLytely as compared to Visicol as bowel preparations before colonoscopic examination. 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 Visicol
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to May 2002
- 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 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, 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).
- Subjects with electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia must have them corrected prior to study participation.
- 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, severe inflammatory bowel disease, ileus, acute alimentary tract surgery, significant gastroparesis or gastric outlet obstruction, appendicitis, gastric retention, toxic colitis, toxic megacolon, or massive and/or abnormal rectal bleeding.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects with uncontrolled cardiovascular disease.
- Subjects with congestive heart failure.
- Subjects with unstable angina pectoris.
- Subjects with ascites.
Show all 16Show fewer
- Subjects with renal insufficiency.
- 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 who are allergic to sodium phosphate salts.
- Subjects who are currently taking, or plan to take, other sodium phosphate- containing products, such as enemas or non-prescription liquid purgatives.
- 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 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 Comparison of the Efficacy and Safety of Two Bowel Preparations: HalfLytely® (2L NuLYTELY and 20 mg Bisacodyl), and Visicol™ Prior To Colonoscopy.
The objective of this study is to determine the efficacy and safety of HalfLytely as compared to Visicol as bowel preparations before colonoscopic examination.
- Conditions
- Colonoscopy
- Being tested
- HalfLytely, Visicol
- Keywords
- colonoscopy preparation, prep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HalfLytelyDrug
VisicolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation success: preparation rated as "good" or "excellent" by the blinded investigator.
Secondary outcomes (2)
Safety: review of preparation symptoms, adverse events and laboratory testing.
Patient acceptance
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 startJun 2001
- Primary completionMay 2002
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
- Factorial
- Masking
- Single blind
- Enrolment
- 60 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
- NCT00164151
- Sponsor's protocol ID
- F38-23
- 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 Comparison of the Efficacy and Safety of Two Bowel Preparations: HalfLytely® (2L NuLYTELY and 20 mg Bisacodyl), and Visicol™ Prior To Colonoscopy.
- ClinicalTrials.gov ID
- NCT00164151
- Acronym / sponsor ID
- F38-23
- Conditions
- Colonoscopy
- Keywords
- colonoscopy preparation, prep
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- May 2002 (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 objective of this study is to determine the efficacy and safety of HalfLytely as compared to Visicol as bowel preparations before colonoscopic examination.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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, 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).
- Subjects with electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia must have them corrected prior to study participation.
Key exclusion criteria (16 listed)
- Subjects with known or suspected bowel perforation or obstruction, severe inflammatory bowel disease, ileus, acute alimentary tract surgery, significant gastroparesis or gastric outlet obstruction, appendicitis, gastric retention, toxic colitis, toxic megacolon, or massive and/or abnormal rectal bleeding.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects with uncontrolled cardiovascular disease.
- Subjects with congestive heart failure.
- Subjects with unstable angina pectoris.
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 | – |
| Visicol | Drug | – |
Primary outcome
Bowel preparation success: preparation rated as "good" or "excellent" by the blinded investigator.
2 secondary outcomes
Safety: review of preparation symptoms, adverse events and laboratory testing.
Patient acceptance
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
1 site 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 Visicol 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 6 inclusion and 16 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 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?
Bowel preparation success: preparation rated as "good" or "excellent" by the blinded investigator.. 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.