ColonoscopyPhase 3NCT01685853
Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One
A Phase 3 study testing Bisacodyl plus PEG-CS and PEG 4 litres split in people with Colonoscopy, run by European Institute of Oncology at 1 site in Italy.
Trial summary
The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Bisacodyl plus PEG-CS and PEG 4 litres split
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2011to Mar 2012
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-patients undergoing a complete colonoscopy
- Patient written informed consent
Who cannot join
- Pregnant or lactating women or at a risk of becoming pregnant
- Known or suspected gastrointestinal obstruction or perforation; toxic megacolon; major colonic resection Known or suspected hypersensitivity to the active principle and/or formulations' ingredients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One. A Randomized, Observer-blind, Parallel Group, Comparative Study.
The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.
Read the detailed description
Eligible patients will be informed about the aims, procedures, benefits and possible risks of the study prior to sign the informed consent form from day -30 to day-3. They will provide medical history and undergo a physical examination. Patients will be evaluated by a Physician other than the blind Endoscopist. The same responsible person will instruct the patients about administration procedures in both oral and written form. The patients will be assigned to receive one of the dosing schedule bowel preparation according to a computer generated block-randomisation list. Patients will take the study treatment at home according to the given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation taken by the patient. Completed colonoscopic exam will be performed with time recorded (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about safety, tolerability, overall acceptance and compliance.
- Conditions
- Colonoscopy
- Being tested
- Bisacodyl plus PEG-CS, PEG 4 litres split
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisacodyl plus PEG-CSDrug
Also called LOVOLdyl plus LOVOLesse
- the day before colonoscopy: 3-4 bisacodyl tablets (according to patient bowel habit) at bedtime
- the morning of colonoscopy: PEG-CS (2 litres) starting 5 hours before the exam
PEG 4 litres splitDrug
Also called SELG 1000
- the day before colonoscopy: 2 litres of PEG
- the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination
| Study group | Role | What they receive |
|---|---|---|
| PEG 4 litres split | Active comparator | Polyethylene glycol with electrolytes (PEG) Receives: Drug: PEG 4 litres split |
| Bisacodyl plus PEG-CS | Experimental | Bisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS) Receives: Drug: Bisacodyl plus PEG-CS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Evaluation of the quality of bowel preparation according to the Ottawa Scale
Measured: 20 min
Secondary outcomes (6)
Efficacy
Evaluation of the mucosal visibility according to a 3 point scale (0-2)
Measured: 20 min
Efficacy
Adenoma detection rate
Measured: 20 min
Safety
Recording of all adverse events occurred during the study by patient questioning
Measured: 24 hours
Tolerability
rate of patients in the two groups who developed GI symptoms related to bowel preparation
Measured: 24 hours
Acceptability
willingness to repeat the preparation
Measured: 24 hours
Compliance
rate of patient with intake of at least 75% of bowel preparation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionMar 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristiano Crosta, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685853
- Sponsor's protocol ID
- IEO S570 510
- Other IDs
- 2010-022967-37
- Status last verified
- Sep 2012
- First submitted
- 12 Sep 2012
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One. A Randomized, Observer-blind, Parallel Group, Comparative Study.
- ClinicalTrials.gov ID
- NCT01685853
- Acronym / sponsor ID
- IEO S570 510
- Conditions
- Colonoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Sep 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 present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.
Detailed description
Eligible patients will be informed about the aims, procedures, benefits and possible risks of the study prior to sign the informed consent form from day -30 to day-3. They will provide medical history and undergo a physical examination. Patients will be evaluated by a Physician other than the blind Endoscopist. The same responsible person will instruct the patients about administration procedures in both oral and written form. The patients will be assigned to receive one of the dosing schedule bowel preparation according to a computer generated block-randomisation list. Patients will take the study treatment at home according to the given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation taken by the patient. Completed colonoscopic exam will be performed with time recorded (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about safety, tolerability, overall acceptance and compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG 4 litres split | Active comparator | Drug: PEG 4 litres splitPolyethylene glycol with electrolytes (PEG) |
| Bisacodyl plus PEG-CS | Experimental | Drug: Bisacodyl plus PEG-CSBisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Out-patients undergoing a complete colonoscopy
- Patient written informed consent
Key exclusion criteria (2 listed)
- Pregnant or lactating women or at a risk of becoming pregnant
- Known or suspected gastrointestinal obstruction or perforation; toxic megacolon; major colonic resection Known or suspected hypersensitivity to the active principle and/or formulations' ingredients
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 |
|---|---|---|
| Bisacodyl plus PEG-CSAlso: LOVOLdyl plus LOVOLesse* the day before colonoscopy: 3-4 bisacodyl tablets (according to patient bowel habit) at bedtime * the morning of colonoscopy: PEG-CS (2 litres) starting 5 hours before the exam | Drug | Bisacodyl plus PEG-CS |
| PEG 4 litres splitAlso: SELG 1000* the day before colonoscopy: 2 litres of PEG * the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination | Drug | PEG 4 litres split |
Primary outcome
Efficacy
Time frame: 20 min
Evaluation of the quality of bowel preparation according to the Ottawa Scale
6 secondary outcomes
Efficacy
Time frame: 20 min
Efficacy
Time frame: 20 min
Safety
Time frame: 24 hours
Tolerability
Time frame: 24 hours
Acceptability
Time frame: 24 hours
Compliance
Time frame: 24 hours
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 19 Sep 2012.
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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.
Cristiano Crosta, MD principal investigator
European Institute of Oncology
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 Bisacodyl plus PEG-CS and PEG 4 litres split in people with Colonoscopy, run by European Institute of Oncology at 1 site in Italy.
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 2 inclusion and 2 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 19 Sep 2012. 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 Italy. 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?
Efficacy (time frame: 20 min). 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 19 Sep 2012.