Bowel Evacuant Prior to ColonoscopyPhase 1NCT01256541
Kristalose as Bowel Evacuant Prior to Colonoscopy
A Phase 1 study testing Kristalose in people with Bowel Evacuant Prior to Colonoscopy, run by Benaroya Research Institute at 1 site in United States.
Trial summary
To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas levels in patients requiring bowel evacuation, and also to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Evacuant Prior to Colonoscopy
- What is being tested?
- Kristalose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2011
- Phase
- Phase 1
- 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 Kristalose.
- Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
- 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, Open-Label, Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Kristalose as a Bowel Evacuant Prior to Colonoscopy
To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas levels in patients requiring bowel evacuation, and also to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant
Read the detailed description
This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant prior to colonoscopy. Prior to colonoscopy, subjects will also undergo evaluation for the production of hydrogen and methane gases in the patient's gut (before and after receiving Kristalose) as assessed by a breath analysis instrument. 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).
- Conditions
- Bowel Evacuant Prior to Colonoscopy
- Being tested
- Kristalose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KristaloseDrug
The dosing regimen of Kristalose will be nine 20-gram doses (one dose every 30 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Kristalose | Experimental | Kristalose as Bowel Evacuant Receives: Drug: Kristalose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydrogen and Methane Gas Production
To evaluate the primary objective of hydrogen and methane gas production as measured by:
- Pre- and post-dose breath analysis for hydrogen and methane gas.
Measured: 3 months
Secondary outcomes (1)
Efficacy
To evaluate the secondary objective of efficacy, the following endpoints will be measured:
- Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.[4]
- 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: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Evacuant Prior to 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256541
- Sponsor's protocol ID
- IRB10068
- Status last verified
- Oct 2011
- First submitted
- 7 Dec 2010
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-Label, Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Kristalose as a Bowel Evacuant Prior to Colonoscopy
- ClinicalTrials.gov ID
- NCT01256541
- Acronym / sponsor ID
- IRB10068
- Conditions
- Bowel Evacuant Prior to Colonoscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center, Cumberland Pharmaceuticals
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Dec 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.
To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas levels in patients requiring bowel evacuation, and also to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant
Detailed description
This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant prior to colonoscopy. Prior to colonoscopy, subjects will also undergo evaluation for the production of hydrogen and methane gases in the patient's gut (before and after receiving Kristalose) as assessed by a breath analysis instrument. 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kristalose | Experimental | Drug: KristaloseKristalose as Bowel Evacuant |
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 (7 listed)
- Patients with galactosemia (galactose-sensitive diet).
- Patients known to be hypersensitive to any of the components of Kristalose.
- Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
- 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.
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 |
|---|---|---|
| KristaloseThe dosing regimen of Kristalose will be nine 20-gram doses (one dose every 30 minutes for 4 straight hours) taken the evening before the colonoscopy procedure. | Drug | Kristalose |
Primary outcome
Hydrogen and Methane Gas Production
Time frame: 3 months
To evaluate the primary objective of hydrogen and methane gas production as measured by: • Pre- and post-dose breath analysis for hydrogen and methane gas.
1 secondary outcome
Efficacy
Time frame: 3 months
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 6 Oct 2011.
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 1 study testing Kristalose in people with Bowel Evacuant Prior to 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 7 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 6 Oct 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Hydrogen and Methane Gas Production (time frame: 3 months). 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 6 Oct 2011.