ColonoscopyPhase 2NCT00312481
MOVIPREP® Versus PICOLAX® Pilot Study
A Phase 2 study testing macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate and NA picosulfate magnesium citrate in people with Colonoscopy, run by Norgine at 1 site in United Kingdom.
Trial summary
This will be a randomised, single-centre, single-blind, parallel-group, pilot study in patients undergoing colonoscopy. The primary objective is to evaluate the efficacy of MOVIPREP® versus PICOLAX® for gut cleansing prior to colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate and NA picosulfate magnesium citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2005to May 2006
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent obtained prior to inclusion
- male or female, aged 18 to 80 years, inclusive, scheduled to undergo a complete 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
- if an adequate method of contraception is not being used, the patient will be post hysterectomy, post bilateral oophorectomy, post menopause or have any other condition which precludes pregnancy
- females of childbearing potential must undergo a pregnancy test
Who cannot join
- ileus
- gastro-intestinal obstruction or perforation
- toxic megacolon, toxic colitis
- congestive heart failure (New York Heart Association [NYHA] III + IV)
- acute life-threatening cardiovascular disease
- acute surgical abdominal conditions
Show all 9Show fewer
- untreated or uncontrolled arterial hypertension
- known clinically significant reduced renal function with creatinine > 170 µmol/L
- known clinically significant reduced liver function
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
John Radcliffe Hospital, Department of Gastroenterology, Endoscopy Unit, Headley Way, Headington
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: A Randomised, Single-Centre, Parallel-Group, Pilot Study to Assess the Efficacy, Safety and Patient Acceptability of a New 2-Litre Bowel Preparation Agent (MOVIPREP®) Compared With a Standard Bowel Preparation Agent (PICOLAX®)
This will be a randomised, single-centre, single-blind, parallel-group, pilot study in patients undergoing colonoscopy.
The primary objective is to evaluate the efficacy of MOVIPREP® versus PICOLAX® for gut cleansing prior to colonoscopy.
The secondary objectives are to evaluate the safety, tolerability and acceptability of MOVIPREP versus PICOLAX for gut cleansing prior to colonoscopy.
Read the detailed description
Gut cleansing will be performed using a split dose of MOVIPREP®, 1-litre solution (1x sachet A and 1x sachet B) in the evening prior to the day of colonoscopy and 1-litre solution (1x sachet A and 1x sachet B) in the morning of the colonoscopy, or PICOLAX®, 150 mL solution (1 sachet) before 8am on day prior to the day of colonoscopy, and 150 mL solution (1 sachet) 6 to 8 hours later.
The primary efficacy measure will be the degree of gut cleansing, as assessed by the physician performing the colonoscopy. A 5-grade scale will be used to assess each of the predefined colon areas, resulting in a final grading (A to D) of the overall quality of the bowel preparation treatment. Grades A and B will be considered as success, and Grades C and D as failure.
The secondary efficacy measures will be:
- is it necessary for the patient to return for a further colonoscopy due to insufficient clearance/cleansing of colon prior to the normal schedule for a repeat procedure?
- taste acceptability
- ease of taking, and ability to complete the bowel preparation treatment
- recommended diet compliance
- would the patient be prepared to repeat the bowel preparation treatment if necessary?
- well-being and effect on usual activities whilst taking the bowel preparation treatment
- overall impression of the bowel preparation treatment prior to colonoscopy
- symptoms experienced since taking their first study bowel preparation treatment and prior to their colonoscopy
Safety and tolerability will be assessed through the collection of adverse events, clinical laboratory tests, physical examination, weight and vital signs (blood pressure and pulse rate) data.
Number of patients:
It is intended to recruit approximately 70 patients in order to achieve at least 60 evaluable patients using a randomisation ratio of 1:1 MOVIPREP®: PICOLAX®.
- Conditions
- Colonoscopy
- Being tested
- macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate, NA picosulfate magnesium citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbateDrug
Also called MOVIPREP
Split dose, 1-litre solution in the evening prior to colonoscopy and second dose in the morning prior to colonoscopy
NA picosulfate magnesium citrateDrug
150 ml solution before 8am on day prior to colonoscopy and 150ml solution 6 to 8 hours later.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MOVIPREP Receives: Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate |
| 2 | Active comparator | Picolax Receives: Drug: NA picosulfate magnesium citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall quality of the bowel preparation treatment, based on the degree of gut cleansing of each section of the colon.
Measured: 8 days
Secondary outcomes (8)
is it necessary for the patient to return for a further colonoscopy due to insufficient clearance/cleansing of colon prior to the normal schedule for a repeat procedure?
Measured: within 3 months
taste acceptability
Measured: 8 days
ease of taking, and ability to complete, the bowel preparation treatment
Measured: 8 days
recommended diet compliance
Measured: 8 days
would the patient be prepared to repeat the bowel preparation treatment if necessary?
Measured: 8 days
well-being and effect on usual activities whilst taking the bowel preparation treatment
Measured: 8 days
overall impression of the bowel preparation treatment prior to colonoscopy
Measured: 8 days
symptoms experienced since taking their first study bowel preparation treatment and prior to their colonoscopy
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startJul 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mike Geraint, MD, Study director, Norgine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312481
- Sponsor's protocol ID
- NRL994-02-2004
- Status last verified
- Dec 2007
- First submitted
- 6 Apr 2006
- Last updated
- 17 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Hookey LC, Depew WT, Vanner SJ. A prospective randomized trial comparing low-dose oral sodium phosphate plus stimulant laxatives with large volume polyethylene glycol solution for colon cleansing. Am J Gastroenterol. 2004 Nov;99(11):2217-22. doi: 10.1111/j.1572-0241.2004.40482.x.
PubMed 15555005Worthington J, Thyssen M, Chapman G, Chapman R, Geraint M. A randomised controlled trial of a new 2 litre polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy. Curr Med Res Opin. 2008 Feb;24(2):481-8. doi: 10.1185/030079908x260844.
PubMed 18179734
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-Centre, Parallel-Group, Pilot Study to Assess the Efficacy, Safety and Patient Acceptability of a New 2-Litre Bowel Preparation Agent (MOVIPREP®) Compared With a Standard Bowel Preparation Agent (PICOLAX®)
- ClinicalTrials.gov ID
- NCT00312481
- Acronym / sponsor ID
- NRL994-02-2004
- Conditions
- Colonoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- May 2006 (actual)
- First posted
- 10 Apr 2006 (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.
This will be a randomised, single-centre, single-blind, parallel-group, pilot study in patients undergoing colonoscopy.
The primary objective is to evaluate the efficacy of MOVIPREP® versus PICOLAX® for gut cleansing prior to colonoscopy.
The secondary objectives are to evaluate the safety, tolerability and acceptability of MOVIPREP versus PICOLAX for gut cleansing prior to colonoscopy.
Detailed description
Gut cleansing will be performed using a split dose of MOVIPREP®, 1-litre solution (1x sachet A and 1x sachet B) in the evening prior to the day of colonoscopy and 1-litre solution (1x sachet A and 1x sachet B) in the morning of the colonoscopy, or PICOLAX®, 150 mL solution (1 sachet) before 8am on day prior to the day of colonoscopy, and 150 mL solution (1 sachet) 6 to 8 hours later.
The primary efficacy measure will be the degree of gut cleansing, as assessed by the physician performing the colonoscopy. A 5-grade scale will be used to assess each of the predefined colon areas, resulting in a final grading (A to D) of the overall quality of the bowel preparation treatment. Grades A and B will be considered as success, and Grades C and D as failure.
The secondary efficacy measures will be:
- is it necessary for the patient to return for a further colonoscopy due to insufficient clearance/cleansing of colon prior to the normal schedule for a repeat procedure?
- taste acceptability
- ease of taking, and ability to complete the bowel preparation treatment
- recommended diet compliance
- would the patient be prepared to repeat the bowel preparation treatment if necessary?
- well-being and effect on usual activities whilst taking the bowel preparation treatment
- overall impression of the bowel preparation treatment prior to colonoscopy
- symptoms experienced since taking their first study bowel preparation treatment and prior to their colonoscopy
Safety and tolerability will be assessed through the collection of adverse events, clinical laboratory tests, physical examination, weight and vital signs (blood pressure and pulse rate) data.
Number of patients:
It is intended to recruit approximately 70 patients in order to achieve at least 60 evaluable patients using a randomisation ratio of 1:1 MOVIPREP®: PICOLAX®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbateMOVIPREP |
| 2 | Active comparator | Drug: NA picosulfate magnesium citratePicolax |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- written informed consent obtained prior to inclusion
- male or female, aged 18 to 80 years, inclusive, scheduled to undergo a complete 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
- if an adequate method of contraception is not being used, the patient will be post hysterectomy, post bilateral oophorectomy, post menopause or have any other condition which precludes pregnancy
Key exclusion criteria (9 listed)
- ileus
- gastro-intestinal obstruction or perforation
- toxic megacolon, toxic colitis
- congestive heart failure (New York Heart Association [NYHA] III + IV)
- acute life-threatening cardiovascular disease
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 |
|---|---|---|
| macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbateAlso: MOVIPREPSplit dose, 1-litre solution in the evening prior to colonoscopy and second dose in the morning prior to colonoscopy | Drug | 1 |
| NA picosulfate magnesium citrate150 ml solution before 8am on day prior to colonoscopy and 150ml solution 6 to 8 hours later. | Drug | 2 |
Primary outcome
Overall quality of the bowel preparation treatment, based on the degree of gut cleansing of each section of the colon.
Time frame: 8 days
8 secondary outcomes
is it necessary for the patient to return for a further colonoscopy due to insufficient clearance/cleansing of colon prior to the normal schedule for a repeat procedure?
Time frame: within 3 months
taste acceptability
Time frame: 8 days
ease of taking, and ability to complete, the bowel preparation treatment
Time frame: 8 days
recommended diet compliance
Time frame: 8 days
would the patient be prepared to repeat the bowel preparation treatment if necessary?
Time frame: 8 days
well-being and effect on usual activities whilst taking the bowel preparation treatment
Time frame: 8 days
overall impression of the bowel preparation treatment prior to colonoscopy
Time frame: 8 days
symptoms experienced since taking their first study bowel preparation treatment and prior to their colonoscopy
Time frame: 8 days
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 17 Dec 2007.
- Background: PubMed 15555005Hookey LC, Depew WT, Vanner SJ. A prospective randomized trial comparing low-dose oral sodium phosphate plus stimulant laxatives with large volume polyethylene glycol solution for colon cleansing. Am J Gastroenterol. 2004 Nov;99(11):2217-22. doi: 10.1111/j.1572-0241.2004.40482.x.
- Derived from this study: PubMed 18179734Worthington J, Thyssen M, Chapman G, Chapman R, Geraint M. A randomised controlled trial of a new 2 litre polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy. Curr Med Res Opin. 2008 Feb;24(2):481-8. doi: 10.1185/030079908x260844.
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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.
Mike Geraint, MD study director
Norgine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate and NA picosulfate magnesium citrate in people with Colonoscopy, run by Norgine at 1 site in United Kingdom.
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 9 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 17 Dec 2007. 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Overall quality of the bowel preparation treatment, based on the degree of gut cleansing of each section of the colon. (time frame: 8 days). 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 NCT00312481, which also lists 2 linked publications.
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 17 Dec 2007.