Gastrointestinal HemorrhagePhase 4NCT01169220
Bowel Preparation for Inpatient Colonoscopy
A Phase 4 study testing Go-Lytely and Go Lytely in people with Gastrointestinal Hemorrhage and Colon Cancer, run by Santa Clara Valley Health & Hospital System at 1 site in United States.
Trial summary
This study will compare two strategies for bowel cleansing prior to inpatient colonoscopy: the entire preparation taken the night before the procedure versus half the preparation taken the night before the procedure, and the other half taken the morning of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage, Colon Cancer, Diverticulosis
- What is being tested?
- Go-Lytely and Go Lytely
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 2014
- 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
- any diagnosis for which colonoscopy is indicated
Who cannot join
- ileus
- severe colitis/toxic megacolon
- gastric retention
- bowel perforation
- gastrointestinal obstruction
- gastroparesis that precludes oral bowel preparation
Show all 9Show fewer
- pregnant or lactating women
- allergy to polyethylene glycol.
- unable to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Santa Clara Valley Medical Center
San Jose, California, 95128
About this study
Official title: Single Blind, Randomized, Controlled Trial of Conventional Versus Split-Dose Bowel Preparation for Inpatient Colonoscopy
This study will compare two strategies for bowel cleansing prior to inpatient colonoscopy: the entire preparation taken the night before the procedure versus half the preparation taken the night before the procedure, and the other half taken the morning of the procedure.
- Conditions
- Gastrointestinal Hemorrhage, Colon Cancer, Diverticulosis
- Being tested
- Go-Lytely, Go Lytely
- Keywords
- Colonoscopy, Bowel preparation
- Medical subject headings
- Gastrointestinal Hemorrhage, Colonic Neoplasms, Diverticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go-LytelyDrug
Bowel cleansing agent
Go LytelyDrug
Bowel cleansing agent
| Study group | Role | What they receive |
|---|---|---|
| Split prep | Experimental | Not described Receives: Drug: Go Lytely |
| Whole prep | Active comparator | Not described Receives: Drug: Go-Lytely |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of colon cleansing
Measured: 24 hours from study enrollment
Secondary outcomes (1)
Patient satisfaction
Measured: 24 hours from study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Clara Valley Health & Hospital System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169220
- Sponsor's protocol ID
- 10-041
- Status last verified
- Oct 2017
- First submitted
- 20 Jul 2010
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blind, Randomized, Controlled Trial of Conventional Versus Split-Dose Bowel Preparation for Inpatient Colonoscopy
- ClinicalTrials.gov ID
- NCT01169220
- Acronym / sponsor ID
- 10-041
- Conditions
- Gastrointestinal Hemorrhage, Colon Cancer, Diverticulosis
- Keywords
- Colonoscopy, Bowel preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Santa Clara Valley Health & Hospital SystemUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Jul 2010 (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 study will compare two strategies for bowel cleansing prior to inpatient colonoscopy: the entire preparation taken the night before the procedure versus half the preparation taken the night before the procedure, and the other half taken the morning of the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Split prep | Experimental | Drug: Go Lytely |
| Whole prep | Active comparator | Drug: Go-Lytely |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any diagnosis for which colonoscopy is indicated
Key exclusion criteria (9 listed)
- ileus
- severe colitis/toxic megacolon
- gastric retention
- bowel perforation
- gastrointestinal obstruction
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 |
|---|---|---|
| Go-LytelyBowel cleansing agent | Drug | Whole prep |
| Go LytelyBowel cleansing agent | Drug | Split prep |
Primary outcome
Quality of colon cleansing
Time frame: 24 hours from study enrollment
1 secondary outcome
Patient satisfaction
Time frame: 24 hours from study enrollment
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 5 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Go-Lytely and Go Lytely in people with Gastrointestinal Hemorrhage and Colon Cancer, run by Santa Clara Valley Health & Hospital System 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 1 inclusion and 9 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 5 Oct 2017. 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?
Quality of colon cleansing (time frame: 24 hours from study enrollment). 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 5 Oct 2017; AzTrials last refreshed its copy on 31 Oct 2026.