ColonoscopyNCT01705262
Comparing Oral Preparation With Macrogol (Moviprep) and Natriumdihydrogenphosphatdihydrat (Phosphoral)
An observational study of Colonoscopy, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether Moviprep or Phosphoral is the best method of bowel preparation before colonoscopy - seen by the patients and by the endoscopist. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Oct 2012
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred to colonoscopy by the house doctors
Who may be able to join
- primary diagnostic colonoscopy,
- colonoscopy as a follow-up,
- intended therapeutic colonoscopy.
Who cannot join
- patients younger than 18 years
- pregnancy
- known bowl obstructions
- known inflammatory colon disease
- known kidney disease
- phenylketonuri
- glucose-6-phospat deficiency
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether Moviprep or Phosphoral is the best method of bowel preparation before colonoscopy - seen by the patients and by the endoscopist.
- Conditions
- Colonoscopy
- Keywords
- compliance, Bowel preparations, Moviprep, Phosphoral
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| u-65 M | Male patients under 65 | |
| u-65 K | Female patients under 65 years old | |
| o-65 -K | Female patients over 65 years | |
| O-65 M | Male patients over 65 years |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Phophoral was no longer used as a preparation before coloscopies at OUH
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.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Reiss Axelsen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705262
- Sponsor's protocol ID
- AAX-001
- Status last verified
- Apr 2017
- First submitted
- 27 Jan 2012
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Oral Preparation With Macrogol (Moviprep) and Natriumdihydrogenphosphatdihydrat (Phosphoral)
- ClinicalTrials.gov ID
- NCT01705262
- Acronym / sponsor ID
- AAX-001
- Conditions
- Colonoscopy
- Keywords
- compliance, Bowel preparations, Moviprep, Phosphoral
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Phophoral was no longer used as a preparation before coloscopies at OUH
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 Oct 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 purpose of this study is to determine whether Moviprep or Phosphoral is the best method of bowel preparation before colonoscopy - seen by the patients and by the endoscopist.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| u-65 M | – | –Male patients under 65 |
| u-65 K | – | –Female patients under 65 years old |
| o-65 -K | – | –Female patients over 65 years |
| O-65 M | – | –Male patients over 65 years |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to colonoscopy by the house doctors
Key inclusion criteria (3 listed)
- primary diagnostic colonoscopy,
- colonoscopy as a follow-up,
- intended therapeutic colonoscopy.
Key exclusion criteria (7 listed)
- patients younger than 18 years
- pregnancy
- known bowl obstructions
- known inflammatory colon disease
- known kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Phophoral was no longer used as a preparation before coloscopies at OUH). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by Odense University 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Apr 2017. 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 was stopped early (reason given: Phophoral was no longer used as a preparation before coloscopies at OUH). Results are not available in the source record.
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.
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 5 Apr 2017.