ColonoscopyPhase 2NCT01650870
Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults
A Phase 2 study testing Crystalline Lactulose in people with Colonoscopy, run by Benaroya Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale (BBPS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Crystalline Lactulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 2012
- Phase
- Phase 2
- 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
- Patients requiring bowel evacuation for colonoscopy
Who cannot join
- Patients with galactosemia (galactose-sensitive diet)
- Patients known to be hypersensitive to any of the components of Crystalline Lactulose
- Patients with a history of a failed bowel preparation
- Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives
- Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus
- Patients on lactulose therapy or receiving any treatment for chronic constipation
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- Patients less than 18 years of age
- Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions
- Be pregnant or nursing
- Be otherwise unsuitable for the study, in the opinion of the Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: A Single Center, Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Split-Dose Regimen of Crystalline Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale (BBPS).
Read the detailed description
This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of a split-dose regimen of Crystalline Lactulose for cleansing of the colon prior to colonoscopy. Safety will be assessed by the occurrence of any treatment emergent adverse events. Efficacy will be determined by the endoscopist's rating of the cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of the bowel). Patient preference will be determined by the patient's responses on a patient questionnaire.
- Conditions
- Colonoscopy
- Being tested
- Crystalline Lactulose
- Keywords
- Cathartics, Laxatives, Lactulose, Gastrointestinal Agents, Therapeutic Uses, Pharmacologic Actions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystalline LactuloseDrug
| Study group | Role | What they receive |
|---|---|---|
| Evening Only (full-dose) | Active comparator | The dosing regimen of Crystalline lactulose will be four 45-gram doses (one dose every 60 minutes for 4 straight hours) taken the evening before the colonoscopy procedure. Receives: Drug: Crystalline Lactulose |
| Split-dose | Experimental | The dosing regimen of Crystalline lactulose will be three 45-gram doses (one dose every 60 minutes for 3 straight hours) taken the evening before the colonoscopy procedure followed by one 45-gram dose the morning before the colonoscopy procedure. Receives: Drug: Crystalline Lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleanliness of the Colon During Colonoscopy
To evaluate the primary objective of efficacy of the split-dose, the following endpoint will be measured:
- Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.
Measured: Day of the procedure
Secondary outcomes (4)
Treatment Failures
To evaluate the secondary objective of efficacy, the following endpoint will be measured:
- The number and percentage of patient's who by the physician's determination are considered treatment failures (patients with insufficient evacuation of the bowel=Boston bowel prep score < 5, and/or any colon segment score of 0).
Measured: Day of the procedure
Patient Tolerability and Preference
To evaluate the secondary objective of patient tolerability and preference on the basis of the following assessments: Patient tolerability and preference questionnaire including 100 mm Visual Analog Scale (VAS) and Likert Scale
Measured: Day before and day of colonoscopy
Colonic Hydrogen and Methane Gas Production
To evaluate the secondary objective of measuring colonic hydrogen and methane gas production as measured by:
- Colonic hydrogen and methane gas levels.
Measured: Day of colonoscopy
Safety/Adverse Events
To evaluate the secondary objective of safety as measured by the incidence of treatment emergent adverse events
Measured: Day before colonoscopy till 7 days after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionSep 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center, Cumberland Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Otto Lin, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650870
- Sponsor's protocol ID
- SplitDose Cryst. Lactulose
- Status last verified
- Aug 2014
- First submitted
- 23 Jul 2012
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Split-Dose Regimen of Crystalline Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
- ClinicalTrials.gov ID
- NCT01650870
- Acronym / sponsor ID
- SplitDose Cryst. Lactulose
- Conditions
- Colonoscopy
- Keywords
- Cathartics, Laxatives, Lactulose, Gastrointestinal Agents, Therapeutic Uses, Pharmacologic Actions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center, Cumberland Pharmaceuticals
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Jul 2012 (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 this study is to determine the efficacy of a split-dose regimen of crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale (BBPS).
Detailed description
This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of a split-dose regimen of Crystalline Lactulose for cleansing of the colon prior to colonoscopy. Safety will be assessed by the occurrence of any treatment emergent adverse events. Efficacy will be determined by the endoscopist's rating of the cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of the bowel). Patient preference will be determined by the patient's responses on a patient questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evening Only (full-dose) | Active comparator | Drug: Crystalline LactuloseThe dosing regimen of Crystalline lactulose will be four 45-gram doses (one dose every 60 minutes for 4 straight hours) taken the evening before the colonoscopy procedure. |
| Split-dose | Experimental | Drug: Crystalline LactuloseThe dosing regimen of Crystalline lactulose will be three 45-gram doses (one dose every 60 minutes for 3 straight hours) taken the evening before the colonoscopy procedure followed by one 45-gram dose the morning before the colonoscopy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring bowel evacuation for colonoscopy
Key exclusion criteria (10 listed)
- Patients with galactosemia (galactose-sensitive diet)
- Patients known to be hypersensitive to any of the components of Crystalline Lactulose
- Patients with a history of a failed bowel preparation
- Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives
- Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus
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 |
|---|---|---|
| Crystalline Lactulose | Drug | Evening Only (full-dose), Split-dose |
Primary outcome
Cleanliness of the Colon During Colonoscopy
Time frame: Day of the procedure
To evaluate the primary objective of efficacy of the split-dose, the following endpoint will be measured: o Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.
4 secondary outcomes
Treatment Failures
Time frame: Day of the procedure
Patient Tolerability and Preference
Time frame: Day before and day of colonoscopy
Colonic Hydrogen and Methane Gas Production
Time frame: Day of colonoscopy
Safety/Adverse Events
Time frame: Day before colonoscopy till 7 days after colonoscopy
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 8 Aug 2014.
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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.
Otto Lin, MD principal investigator
Virginia Mason Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Crystalline Lactulose in people with Colonoscopy, run by Benaroya Research Institute 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 10 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 8 Aug 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Cleanliness of the Colon During Colonoscopy (time frame: Day of the procedure). 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 8 Aug 2014.