ColonoscopyPhase 4NCT01509131
Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate
A Phase 4 study testing 2L PEG-CS plus bisacodyl and 2L PEG-ASC in people with Colonoscopy, run by Promefarm S.r.l. at 5 sites in Italy.
Trial summary
It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- 2L PEG-CS plus bisacodyl and 2L PEG-ASC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 5 sitesItaly
- Study dates
- Mar 2010to Dec 2010
- 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 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
- Hypersensitivity to any of the ingredients
- History of anaphylaxis to drugs or allergic reactions in general
- Known or suspected gastrointestinal obstruction or perforation
- Toxic megacolon; major colonic resection
- Heart failure (Class III or IV); severe renal failure; relevant diseases, that may interfere with the aim of the study
- Phenylketonuria;Glucose-6-phosphate dehydrogenase deficiency
- Unwillingness to co-operate and to comply with the requirements of the trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Spedali Civili
Brescia, 25123
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
Nuovo Regina Margherita
Roma, 00185
IRCCS Humanitas
Rozzano, Milano, 20089
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013
About this study
Official title: Low Volume Bowel Preparation for Colonoscopy: a Comparison Between PEG-CS Plus Bisacodyl Versus PEG-ASC
It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.
- Conditions
- Colonoscopy
- Being tested
- 2L PEG-CS plus bisacodyl, 2L PEG-ASC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2L PEG-CS plus bisacodylDrug
Also called Lovolesse 2L plus Lovoldyl 5 mg (2-4 tablets)
Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit)
2L PEG-ASCDrug
Also called Moviprep
Patients will asked to take PEG-ASC according to labeling instructions
| Study group | Role | What they receive |
|---|---|---|
| 2L PEG-CS plus bisacodyl | Experimental | Patients will be asked to take 2L PEG-CS plus bisacodyl (10-20 mg according to patient bowel habit) Receives: Drug: 2L PEG-CS plus bisacodyl |
| 2L PEG-ASC | Active comparator | Patients will be asked to take PEG-ASC according to labeling instructions Receives: Drug: 2L PEG-ASC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the quality of bowel preparation by BBPS
BBPS is an established rating scale to evaluate the quality of bowel preparation. A score greater than 6 is considered as success. The rate of success will be compared between the two groups.
Measured: 20 minutes
Secondary outcomes (5)
Difference in mucosal visibility between the two groups
Three point rating scale(0-2).
Measured: 20 minutes
Number of patients with adverse events
Patient questioning.
Measured: 24 hours
Difference in tolerability between the two groups
Difference in the percentage of patients in the two groups who developed GI symptoms related to bowel preparation.
Measured: 24 hours
Difference in patients acceptability between the two groups
Difference in the percentage of patients in the two groups who were willing to repeat the preparation and easy to take the bowel preparation.
Measured: 24 hours
Difference in patients compliance between the two groups
Difference in the percentage of patients who took 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 posted12 Jan 2012 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promefarm S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessandro Repici, MD, Principal investigator, IRCSS Istituto Clinico Humanitas, Rozzano (MI) - ItalyRenzo Cestari, Prof. MD, Principal investigator, Spedali Civili di Brescia, Brescia - ItalyCesare Hassan, MD, Principal investigator, Nuovo Regina Margherita, Roma - ItalyAngelo Andriulli, MD, Principal investigator, IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo - ItalyVito Annese, MD, Principal investigator, Ospedale Careggi, Firenze - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509131
- Sponsor's protocol ID
- PMF105BC1/09
- Status last verified
- Jan 2012
- First submitted
- 4 Jan 2012
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Volume Bowel Preparation for Colonoscopy: a Comparison Between PEG-CS Plus Bisacodyl Versus PEG-ASC
- ClinicalTrials.gov ID
- NCT01509131
- Acronym / sponsor ID
- PMF105BC1/09
- Conditions
- Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Promefarm S.r.l.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Jan 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.
It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2L PEG-CS plus bisacodyl | Experimental | Drug: 2L PEG-CS plus bisacodylPatients will be asked to take 2L PEG-CS plus bisacodyl (10-20 mg according to patient bowel habit) |
| 2L PEG-ASC | Active comparator | Drug: 2L PEG-ASCPatients will be asked to take PEG-ASC according to labeling instructions |
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 (8 listed)
- Pregnant or lactating women or at a risk of becoming pregnant
- Hypersensitivity to any of the ingredients
- History of anaphylaxis to drugs or allergic reactions in general
- Known or suspected gastrointestinal obstruction or perforation
- Toxic megacolon; major colonic resection
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 |
|---|---|---|
| 2L PEG-CS plus bisacodylAlso: Lovolesse 2L plus Lovoldyl 5 mg (2-4 tablets)Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit) | Drug | 2L PEG-CS plus bisacodyl |
| 2L PEG-ASCAlso: MoviprepPatients will asked to take PEG-ASC according to labeling instructions | Drug | 2L PEG-ASC |
Primary outcome
Evaluation of the quality of bowel preparation by BBPS
Time frame: 20 minutes
BBPS is an established rating scale to evaluate the quality of bowel preparation. A score greater than 6 is considered as success. The rate of success will be compared between the two groups.
5 secondary outcomes
Difference in mucosal visibility between the two groups
Time frame: 20 minutes
Number of patients with adverse events
Time frame: 24 hours
Difference in tolerability between the two groups
Time frame: 24 hours
Difference in patients acceptability between the two groups
Time frame: 24 hours
Difference in patients compliance between the two groups
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 12 Jan 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.
Alessandro Repici, MD principal investigator
IRCSS Istituto Clinico Humanitas, Rozzano (MI) - Italy
Renzo Cestari, Prof. MD principal investigator
Spedali Civili di Brescia, Brescia - Italy
Cesare Hassan, MD principal investigator
Nuovo Regina Margherita, Roma - Italy
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2L PEG-CS plus bisacodyl and 2L PEG-ASC in people with Colonoscopy, run by Promefarm S.r.l. at 5 sites 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 8 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 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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?
Evaluation of the quality of bowel preparation by BBPS (time frame: 20 minutes). 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 12 Jan 2012.