Colonoscopy PreparationPhase 2NCT02123017
Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy
A Phase 2 study testing 90 grams of Crystalline Lactulose, 135 grams of Crystalline Lactulose and 180 grams of Crystalline Lactulose in people with Colonoscopy Preparation, run by Cumberland Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy Preparation
- What is being tested?
- 90 grams of Crystalline Lactulose, 135 grams of Crystalline Lactulose and 180 grams of Crystalline Lactulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- 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 lactulose for oral solution.
- Patients with a known abnormality on screening or a vital sign assessments that, in the Investigator's judgment, may pose a significant risk including those pertaining to dehydration or electrolyte shifts.
- Patients with a history of impaired renal function.
- Patients with current or recent history of hypotension, as defined by the Investigator.
- Patients with a history of long Q-T syndrome.
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- 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, gastric retention, bowel perforation, toxic colitis, toxic megacolon, ileus or previous colonic surgery (except hemorrhoidectomy and polypectomy).
- Patients on lactulose therapy or receiving any treatment for chronic constipation.
- Be pregnant or nursing.
- Patients expected to require electrocautery or argon plasma coagulation.
- 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 otherwise unsuitable for the study, in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observer-blinded, Dose-finding Study to Investigate the Safety, Efficacy, and Patient Preference of Lactulose for Oral Solution With Bisacodyl for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy.
- Conditions
- Colonoscopy Preparation
- Being tested
- 90 grams of Crystalline Lactulose, 135 grams of Crystalline Lactulose, 180 grams of Crystalline Lactulose
- Keywords
- Bowel Evacuation, Colonoscopy Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90 grams of Crystalline LactuloseDrug
15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses
135 grams of Crystalline LactuloseDrug
15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses
180 grams of Crystalline LactuloseDrug
15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses
| Study group | Role | What they receive |
|---|---|---|
| 90 grams of Crystalline Lactulose | Experimental | 15 mg of bisacodyl, plus 30 grams of crystalline lactulose x three doses Receives: Drug: 90 grams of Crystalline Lactulose |
| 135 grams of Crystalline Lactulose | Experimental | 15 mg of bisacodyl, plus 45 grams of crystalline lactulose x three doses Receives: Drug: 135 grams of Crystalline Lactulose |
| 180 grams of Crystalline Lactulose | Experimental | 15 mg of bisacodyl, plus 60 grams of crystalline lactulose x three doses Receives: Drug: 180 grams of Crystalline Lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.
Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.
Measured: 10-14 hours post last consumption
Secondary outcomes (3)
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence
Safety determined by the incidence of treatment emergent adverse events.
Measured: 1 day post last consumption
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity
Safety determined by the severity of treatment emergent adverse events.
Measured: 1 day post last consumption
Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant
Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable
Measured: 1 day post last consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colonoscopy PreparationStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Krause, MD, Principal investigator, ClinSearch, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123017
- Sponsor's protocol ID
- CPI-KR-005
- Status last verified
- Jan 2016
- First submitted
- 23 Apr 2014
- Last updated
- 24 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observer-blinded, Dose-finding Study to Investigate the Safety, Efficacy, and Patient Preference of Lactulose for Oral Solution With Bisacodyl for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
- ClinicalTrials.gov ID
- NCT02123017
- Acronym / sponsor ID
- CPI-KR-005
- Conditions
- Colonoscopy Preparation
- Keywords
- Bowel Evacuation, Colonoscopy Preparation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Posted 24 Feb 2016
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 study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 90 grams of Crystalline Lactulose | Experimental | Drug: 90 grams of Crystalline Lactulose15 mg of bisacodyl, plus 30 grams of crystalline lactulose x three doses |
| 135 grams of Crystalline Lactulose | Experimental | Drug: 135 grams of Crystalline Lactulose15 mg of bisacodyl, plus 45 grams of crystalline lactulose x three doses |
| 180 grams of Crystalline Lactulose | Experimental | Drug: 180 grams of Crystalline Lactulose15 mg of bisacodyl, plus 60 grams of crystalline lactulose x three doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring bowel evacuation for colonoscopy.
Key exclusion criteria (15 listed)
- Patients with galactosemia (galactose-sensitive diet).
- Patients known to be hypersensitive to any of the components of lactulose for oral solution.
- Patients with a known abnormality on screening or a vital sign assessments that, in the Investigator's judgment, may pose a significant risk including those pertaining to dehydration or electrolyte shifts.
- Patients with a history of impaired renal function.
- Patients with current or recent history of hypotension, as defined by the Investigator.
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 |
|---|---|---|
| 90 grams of Crystalline Lactulose15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses | Drug | 90 grams of Crystalline Lactulose |
| 135 grams of Crystalline Lactulose15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses | Drug | 135 grams of Crystalline Lactulose |
| 180 grams of Crystalline Lactulose15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses | Drug | 180 grams of Crystalline Lactulose |
Primary outcome
Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.
Time frame: 10-14 hours post last consumption
Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.
3 secondary outcomes
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence
Time frame: 1 day post last consumption
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity
Time frame: 1 day post last consumption
Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant
Time frame: 1 day post last consumption
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Krause, MD principal investigator
ClinSearch, LLC
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 90 grams of Crystalline Lactulose, 135 grams of Crystalline Lactulose and 180 grams of Crystalline Lactulose in people with Colonoscopy Preparation, run by Cumberland Pharmaceuticals 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 15 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 24 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Bisacodyl and Lactulose as a Preparation for Colonoscopy. (time frame: 10-14 hours post last consumption). 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 24 Feb 2016.