Colorectal CancerNCT01519609
Trial Comparing Moviprep and Phosphoral as Bowel Prep Before Colonoscopy
A study testing bowel prep before endoscopy in people with Colorectal Cancer, run by Randers Regional Hospital at 1 site in Denmark.
Trial summary
Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major single center has docuemted the advantage of using moviprep as bowel prep before colonoscopy.This randomised study was conducted to compare moviprep with the present standard: Phosphoral to investigate the degree of bowel cleasing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- bowel prep before endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Nov 2012
- Phase
- Interventional
- 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 suspected of colorectal cancer scheduled for colonoscopy
Who cannot join
- Patients with previous colorectal surgery
- Colonis Stenosis
- ASA > 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Randomised Trial Comparing Moviprep and Phosphoral as Bowel Prep Before
Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major single center has docuemted the advantage of using moviprep as bowel prep before colonoscopy.This randomised study was conducted to compare moviprep with the present standard: Phosphoral to investigate the degree of bowel cleasing before colonoscopy in patients suspected of colorectal cancer, and to investigate number of days where patients need to stay home.
- Conditions
- Colorectal Cancer
- Being tested
- bowel prep before endoscopy
- Keywords
- Bowel prep, Safety, Efficacy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bowel prep before endoscopyDrug
bowel prep before colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Moviprep | Active comparator | Moviprep bowel preb Receives: Drug: bowel prep before endoscopy |
| Phosphoral | Active comparator | Bowel prep Receives: Drug: bowel prep before endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of bowel cleansing
Will be estimated by the patients and the colonoscopist
Measured: 1 Day of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Randers Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thorbjorn Sommer, Randers Regional Hospital
- Investigators
- thorbjorn sommer, ph.D, Study director, unaffilated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519609
- Sponsor's protocol ID
- Randers-Moviprep
- Status last verified
- Nov 2012
- First submitted
- 16 Sep 2011
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomised Trial Comparing Moviprep and Phosphoral as Bowel Prep Before
- ClinicalTrials.gov ID
- NCT01519609
- Acronym / sponsor ID
- Randers-Moviprep
- Conditions
- Colorectal Cancer
- Keywords
- Bowel prep, Safety, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Randers Regional HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 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.
Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major single center has docuemted the advantage of using moviprep as bowel prep before colonoscopy.This randomised study was conducted to compare moviprep with the present standard: Phosphoral to investigate the degree of bowel cleasing before colonoscopy in patients suspected of colorectal cancer, and to investigate number of days where patients need to stay home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moviprep | Active comparator | Drug: bowel prep before endoscopyMoviprep bowel preb |
| Phosphoral | Active comparator | Drug: bowel prep before endoscopyBowel prep |
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 suspected of colorectal cancer scheduled for colonoscopy
Key exclusion criteria (3 listed)
- Patients with previous colorectal surgery
- Colonis Stenosis
- ASA > 2
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 |
|---|---|---|
| bowel prep before endoscopybowel prep before colonoscopy | Drug | Moviprep, Phosphoral |
Primary outcome
Degree of bowel cleansing
Time frame: 1 Day of colonoscopy
Will be estimated by the patients and the colonoscopist
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 21 Nov 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.
thorbjorn sommer, ph.D study director
unaffilated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bowel prep before endoscopy in people with Colorectal Cancer, run by Randers Regional Hospital at 1 site in Denmark.
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 3 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 21 Nov 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 Denmark. 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.
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?
Degree of bowel cleansing (time frame: 1 Day of colonoscopy). 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 21 Nov 2012.