Colon CleansingPhase 4MAGIC-PNCT01909219
PMC Split Preparation for Colon Cleansing
A Phase 4 study testing Sodium picosulphate/magnesium Citrate in people with Colon Cleansing, run by Luigi Sacco University Hospital at 2 sites in Italy.
Trial summary
This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated to higher efficacy and acceptability in comparison to the standard dose regimen in bowel cleansing before colonoscopy Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cleansing
- What is being tested?
- Sodium picosulphate/magnesium Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 862 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2012to Apr 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult outpatients
- aged 18-85 yr
- undergoing elective colonoscopy
Who cannot join
- previous colon resection,
- ileus,
- intestinal obstruction,
- toxic megacolon,
- severe heart failure (NYHA Class III or IV),
- acute cardiovascular disease,
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- uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure >100 mmHg),
- severe liver cirrhosis (Child-Pugh score C),
- renal failure (creatinine clearance<30 mL/minute),
- ascites,
- phenylketonuria,
- glucose-6-phosphate dehydrogenase deficiency,
- pregnant or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Luigi Sacco University Hospital
Milan, Milano, I-20157
Luigi Sacco University Hospital
Milan, I-20157
About this study
Official title: A Randomized Controlled Trial Comparing Efficacy and Acceptability of Split and Standard Dose Sodium Picosulphate/Magnesium Citrate for Bowel Cleansing Prior to Colonoscopy: the MAGIC-P Multicenter Study
This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated to higher efficacy and acceptability in comparison to the standard dose regimen in bowel cleansing before colonoscopy
Read the detailed description
Picosulphate/magnesium citrate is a very effective, safe and tolerated low-volume preparation for colon cleansing. This study evaluates whether split dosing is associated to a further increase in efficacy and acceptability in comparison to the standard dose regimen. This is a multicenter, randomized, single-blind study performed in 15 endoscopic services in Italy.
Adult outpatients undergoing colonoscopy will receive picosulphate/magnesium citrate either in the standard dosing (group A, two sachets the day before endoscopy), or in the split dosing (group B, the second dose in the morning of colonoscopy). Bowel cleansing will be assessed using the Boston Scale (BBPS) and rated as adequate if >2 in each segment. Patient acceptance, satisfaction, and related symptoms will be also recorded.
- Conditions
- Colon Cleansing
- Being tested
- Sodium picosulphate/magnesium Citrate
- Keywords
- preparation, cleansing, colon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium picosulphate/magnesium CitrateDrug
Also called Citrafleet
Comparison of two different dosing regimens of sodium picosulphate/magnesium citrate
| Study group | Role | What they receive |
|---|---|---|
| Group A: standard regimen | Active comparator | Patients in the group A (standard regimen) will be instructed to take the two sachets of sodium picosulphate/magnesium citrate diluted in a glass of water 2-4 hours apart, starting at 5 pm the day before colonoscopy. Receives: Drug: Sodium picosulphate/magnesium Citrate |
| Group B | Active comparator | Patients in the group B (split regimen) will be instructed to take the first sachet of sodium picosulphate/magnesium citrate at 7 pm the day before colonoscopy and the second one at 6 am in the morning on the day of colonoscopy. Receives: Drug: Sodium picosulphate/magnesium Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adequate colon cleansing
The primary endpoint of the study was the quality of overall colon cleansing, assessed by the endoscopist. Colon cleansing quality was dichotomized as "adequate" (score > 2 in each colon segment) or "inadequate" (score < 2 in one or more colon segments
Measured: 24 hrs
Secondary outcomes (1)
Patients' acceptance, tolerability and compliance to the cleansing regimen
The overall tolerance of the preparation and the severity of symptoms during the preparation period will be rated on a scale ranging from 0 (no discomfort) to 3 (severe discomfort). Patient acceptance of the preparation will be evaluated by a questionnaire with a 5-point scale ranging from 1 (worse) to 5 (best), assessing interference with daily activity, palatability, easiness in taking the product and the adjunctive clear fluid, and taste of product. Moreover, a nurse will ask the patient whether s/he have completed the prescribed regimen: compliance will be defined as poor for patients who consume less than 75% of product. Willingness to repeat the same preparation in the future will be also recorded.
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionApr 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 Colon CleansingStudies 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
- Investigator
- Enrolment
- 862 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luigi Sacco University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianpiero Manes, Luigi Sacco University Hospital
- Investigators
- Gianpiero Manes, MD, Principal investigator, Sacco Huniversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909219
- Sponsor's protocol ID
- PMC split
- Acronym
- MAGIC-P
- Status last verified
- Jul 2013
- First submitted
- 24 Jul 2013
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manes G, Repici A, Hassan C; MAGIC-P study group. Randomized controlled trial comparing efficacy and acceptability of split- and standard-dose sodium picosulfate plus magnesium citrate for bowel cleansing prior to colonoscopy. Endoscopy. 2014 Aug;46(8):662-9. doi: 10.1055/s-0034-1365800. Epub 2014 Jul 14.
PubMed 25019969
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Efficacy and Acceptability of Split and Standard Dose Sodium Picosulphate/Magnesium Citrate for Bowel Cleansing Prior to Colonoscopy: the MAGIC-P Multicenter Study
- ClinicalTrials.gov ID
- NCT01909219
- Acronym / sponsor ID
- MAGIC-P / PMC split
- Conditions
- Colon Cleansing
- Keywords
- preparation, cleansing, colon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 862 participants (actual)
- Lead sponsor
- Luigi Sacco University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 26 Jul 2013 (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 is an endoscopist-blinded, prospective, multicenter study involving adult outpatients aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated to higher efficacy and acceptability in comparison to the standard dose regimen in bowel cleansing before colonoscopy
Detailed description
Picosulphate/magnesium citrate is a very effective, safe and tolerated low-volume preparation for colon cleansing. This study evaluates whether split dosing is associated to a further increase in efficacy and acceptability in comparison to the standard dose regimen. This is a multicenter, randomized, single-blind study performed in 15 endoscopic services in Italy.
Adult outpatients undergoing colonoscopy will receive picosulphate/magnesium citrate either in the standard dosing (group A, two sachets the day before endoscopy), or in the split dosing (group B, the second dose in the morning of colonoscopy). Bowel cleansing will be assessed using the Boston Scale (BBPS) and rated as adequate if >2 in each segment. Patient acceptance, satisfaction, and related symptoms will be also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: standard regimen | Active comparator | Drug: Sodium picosulphate/magnesium CitratePatients in the group A (standard regimen) will be instructed to take the two sachets of sodium picosulphate/magnesium citrate diluted in a glass of water 2-4 hours apart, starting at 5 pm the day before colonoscopy. |
| Group B | Active comparator | Drug: Sodium picosulphate/magnesium CitratePatients in the group B (split regimen) will be instructed to take the first sachet of sodium picosulphate/magnesium citrate at 7 pm the day before colonoscopy and the second one at 6 am in the morning on the day of colonoscopy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult outpatients
- aged 18-85 yr
- undergoing elective colonoscopy
Key exclusion criteria (13 listed)
- previous colon resection,
- ileus,
- intestinal obstruction,
- toxic megacolon,
- severe heart failure (NYHA Class III or IV),
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 |
|---|---|---|
| Sodium picosulphate/magnesium CitrateAlso: CitrafleetComparison of two different dosing regimens of sodium picosulphate/magnesium citrate | Drug | Group A: standard regimen, Group B |
Primary outcome
Rate of adequate colon cleansing
Time frame: 24 hrs
The primary endpoint of the study was the quality of overall colon cleansing, assessed by the endoscopist. Colon cleansing quality was dichotomized as "adequate" (score > 2 in each colon segment) or "inadequate" (score < 2 in one or more colon segments
1 secondary outcome
Patients' acceptance, tolerability and compliance to the cleansing regimen
Time frame: 24 hrs
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 26 Jul 2013.
- Derived from this study: PubMed 25019969Manes G, Repici A, Hassan C; MAGIC-P study group. Randomized controlled trial comparing efficacy and acceptability of split- and standard-dose sodium picosulfate plus magnesium citrate for bowel cleansing prior to colonoscopy. Endoscopy. 2014 Aug;46(8):662-9. doi: 10.1055/s-0034-1365800. Epub 2014 Jul 14.
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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.
Gianpiero Manes, MD principal investigator
Sacco Huniversity Hospital
2 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 Sodium picosulphate/magnesium Citrate in people with Colon Cleansing, run by Luigi Sacco University Hospital at 2 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 3 inclusion and 13 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 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Rate of adequate colon cleansing (time frame: 24 hrs). 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 NCT01909219, 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 26 Jul 2013.