Colorectal CancerPhase 4NCT01689792
A Multi-centre Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)
A Phase 4 study testing MOVIPREP and CitraFleet in people with Colorectal Cancer, run by Norgine at 1 site in Germany.
Trial summary
To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium Picosulfate/Magnesium Citrate solution. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- MOVIPREP and CitraFleet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Dec 2013
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's written informed consent must be obtained prior to inclusion.
- Male or female outpatients or inpatients aged 40 to 80 years with an indication for complete colonoscopy.
- Willing to undergo a colonoscopy for diagnostic or surveillance purposes
- Patients with a known personal of familial risk of colon neoplasia, willing to undergo a screening colonoscopy
- Willing, able and competent to complete the entire procedure and to comply with study instructions.
- Females of childbearing potential must employ an adequate method of contraception.
Who cannot join
- History of gastric emptying disorders.
- History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation.
- History of phenylketonuria.
- Known glucose-6-phosphate dehydrogenase deficiency.
- Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/sodium ascorbate.
- History of colonic resection.
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- Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs).
- Presence of congestive heart failure (NYHA III + IV).
- Acute life-threatening cardiovascular disease.
- Documented history of severe renal insufficiency (creatinine clearance <30 ml/min).
- Other contraindication described in the summary of product characteristics (SmPC) of either preparation.
- Patient has a condition, clinically significant laboratory results, or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly.
- Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last 3 months.
- Females who are pregnant, nursing or planning a pregnancy.
- Patients who, in the opinion of the investigator, may not be compliant with the study requirements.
- Previous participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre, Randomised, Investigator-blinded Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)
To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium Picosulfate/Magnesium Citrate solution.
- Conditions
- Colorectal Cancer
- Being tested
- MOVIPREP, CitraFleet
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVIPREPDrug
CitraFleetDrug
| Study group | Role | What they receive |
|---|---|---|
| CitraFleet | Active comparator | Administration of CitraFleet Receives: Drug: CitraFleet |
| MOVIPREP | Experimental | Administration of MOVIPREP Receives: Drug: MOVIPREP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp detection rate
Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist
Measured: At colonoscopy
Secondary outcomes (8)
Adenoma Detection Rate (ADR)
ADR, (including flat lesions) defined as number of patients with at least one adenoma as recorded by the pathologist in relation to the total analysis population
Measured: At the Colonoscopy
ADR and PDR by location
ADR and PDR by location:
- left sided (rectum, colon sigmoideum, colon decendens, left half of colon transversum
- right-sided (right half of colon transversum, colon ascendens, caecum
Measured: at the colonoscopy
Cancer detection rate
Cancer detection rate, defined as number of patients with at least one malignancy in relation to the total analysis population
Measured: at the colonoscopy
Flat lesion only detection rate
Flat lesion only detection of the patients
Measured: at the colonoscopy
Advanced risk lesion detection rate
Advanced risk lesion detection rate (lesions >1 cm, low grade and/or villous
Measured: at the colonoscopy
Colonoscopy completion rate
The rate of colonoscopy completion
Measured: at the colonoscopy
Colon cleansing quality
Colon cleansing quality as reported by the gastroenterologist, according to the Harefield Cleansing Scale©
Measured: at the colonoscopy
Acceptability and tolerability of medication using patient questionnaires
The acceptability and tolerability of the study medication taken by the patients throughout the study using specified patient questionnaires
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startNov 2011
- Primary completionJan 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Fishbach, MD, Principal investigator, Klinikum Aschaffenburg-Alzenau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689792
- Sponsor's protocol ID
- NOR-01/2011 (PDR)
- Status last verified
- Dec 2013
- First submitted
- 12 Sep 2012
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pohl J, Halphen M, Kloess HR, Fischbach W. Impact of the quality of bowel cleansing on the efficacy of colonic cancer screening: a prospective, randomized, blinded study. PLoS One. 2015 May 7;10(5):e0126067. doi: 10.1371/journal.pone.0126067. eCollection 2015.
PubMed 25950434
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Investigator-blinded Study Comparing the Polyp Detection Rate of Two Different Types of Bowel Preparation: a 2-litre Solution (MOVIPREP®) Versus a Hyperosmotic and Stimulant Combined Low Volume Bowel Preparation (Sodium Picosulfate and Magnesium Citrate)
- ClinicalTrials.gov ID
- NCT01689792
- Acronym / sponsor ID
- NOR-01/2011 (PDR)
- Conditions
- Colorectal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 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.
To compare the polyp and adenoma detection rate of MOVIPREP versus an oral Sodium Picosulfate/Magnesium Citrate solution.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CitraFleet | Active comparator | Drug: CitraFleetAdministration of CitraFleet |
| MOVIPREP | Experimental | Drug: MOVIPREPAdministration of MOVIPREP |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient's written informed consent must be obtained prior to inclusion.
- Male or female outpatients or inpatients aged 40 to 80 years with an indication for complete colonoscopy.
- Willing to undergo a colonoscopy for diagnostic or surveillance purposes
- Patients with a known personal of familial risk of colon neoplasia, willing to undergo a screening colonoscopy
- Willing, able and competent to complete the entire procedure and to comply with study instructions.
Key exclusion criteria (16 listed)
- History of gastric emptying disorders.
- History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation.
- History of phenylketonuria.
- Known glucose-6-phosphate dehydrogenase deficiency.
- Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/sodium ascorbate.
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 |
|---|---|---|
| MOVIPREP | Drug | MOVIPREP |
| CitraFleet | Drug | CitraFleet |
Primary outcome
Polyp detection rate
Time frame: At colonoscopy
Polyp detection rate defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist
8 secondary outcomes
Adenoma Detection Rate (ADR)
Time frame: At the Colonoscopy
ADR and PDR by location
Time frame: at the colonoscopy
Cancer detection rate
Time frame: at the colonoscopy
Flat lesion only detection rate
Time frame: at the colonoscopy
Advanced risk lesion detection rate
Time frame: at the colonoscopy
Colonoscopy completion rate
Time frame: at the colonoscopy
Colon cleansing quality
Time frame: at the colonoscopy
Acceptability and tolerability of medication using patient questionnaires
Time frame: Throughout the study
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 31 Mar 2015.
- Derived from this study: PubMed 25950434Pohl J, Halphen M, Kloess HR, Fischbach W. Impact of the quality of bowel cleansing on the efficacy of colonic cancer screening: a prospective, randomized, blinded study. PLoS One. 2015 May 7;10(5):e0126067. doi: 10.1371/journal.pone.0126067. eCollection 2015.
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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.
Wolfgang Fishbach, MD principal investigator
Klinikum Aschaffenburg-Alzenau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MOVIPREP and CitraFleet in people with Colorectal Cancer, run by Norgine at 1 site in Germany.
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 6 inclusion and 16 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 31 Mar 2015. 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 Germany. 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?
Polyp detection rate (time frame: At colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01689792, which also lists 1 linked publication.
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 31 Mar 2015.