Colon Cleansing for ColonoscopyPhase 4NCT01603654
Sodium Picosulphate/Magnesium Citrate and Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy
A Phase 4 study testing sodium picosulphate magnesium citrate and low-volume PEG -ascorbic acid in people with Colon Cleansing for Colonoscopy, run by ASST Fatebenefratelli Sacco at 3 sites in Italy.
Trial summary
Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon preparation affects the quality of colon cleansing. The study is aimed at comparing the efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colon Cleansing for Colonoscopy
- What is being tested?
- sodium picosulphate magnesium citrate and low-volume PEG -ascorbic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesItaly
- Study dates
- Jan 2011to Sep 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult outpatients
- aged 18-85 years
- undergoing elective colonoscopy
Who cannot join
- previous colon resection
- ileus
- intestinal obstruction
- toxic megacolon
- severe heart failure (New York Heart Association [NYHA] Class III or IV)
- acute cardiovascular disease
Show all 11Show fewer
- uncontrolled arterial hypertension (systolic pressure > 170 mmHg, diastolic pressure > 100 mmHg)
- severe liver failure or ascites
- end-stage renal failure
- phenylketonuria
- glucose-6-phosphate dehydrogenase deficiency. Women were excluded from the study if they were pregnant, breastfeeding
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale Valduce, Gastroenterologia
Como, 22100
Ospedale S. Paolo
Milan, 20142
Ospedale L. Sacco, Endoscopic Unit
Milan, 20157
About this study
Official title: A Randomized Controlled Trial Comparing the Efficacy and Acceptability of Sodium Picosulphate/Magnesium Citrate With Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy.
Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon preparation affects the quality of colon cleansing. The study is aimed at comparing the efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor bowel preparation.
- Conditions
- Colon Cleansing for Colonoscopy
- Being tested
- sodium picosulphate magnesium citrate, low-volume PEG -ascorbic acid
- Keywords
- Colon preparation, Colonoscopy, Polyethylene glycol, Sodium Picosulphate
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, IBI Lorenzini, Aprilia, Italy
Use of the product in colon cleansing before colonoscopy. Two sachets each containing 10 mg of sodium picosulfate, 3.5 g magnesium oxide and 12.0 g citric acid. The 2 doses are taken diluted in a glass water.
low-volume PEG -ascorbic acidDrug
Also called Moviprep, Norgine Ltd, Harefield, UK
THe product is used as colon cleanser before colonoscopy. It is supplied as a powder for oral use, to be reconstituted with 2 L of water and drunk as a solution. It consists of 100.0 g macrogol 3350 plus electrolytes (7.5 g sodium sulphate, 2.7 g sodium chloride, 1.0 g potassium chloride) and 4.7 g ascorbic acid.
| Study group | Role | What they receive |
|---|---|---|
| sodium picosulphate/magnesium citrate | Experimental | Not described Receives: Drug: sodium picosulphate magnesium citrate |
| low-volume PEG -ascorbic acid | Active comparator | Not described Receives: Drug: low-volume PEG -ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of bowel cleansing
Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products
Measured: Within 24 hrs
Secondary outcomes (2)
Safety
Occurrence of complications related to the intake or the two study products
Measured: In the 24 hours within assumption of study products
Tolerability
Acceptability of the two study products in term of palatability and ease to take the products
Measured: Within 12 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cleansing 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Gianpiero Manes, MD, ASST Fatebenefratelli Sacco
- Investigators
- Gianpiero Manes, MD, Principal investigator, Ospedale L. Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603654
- Sponsor's protocol ID
- Low volume preparations
- Status last verified
- May 2012
- First submitted
- 17 May 2012
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Efficacy and Acceptability of Sodium Picosulphate/Magnesium Citrate With Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy.
- ClinicalTrials.gov ID
- NCT01603654
- Acronym / sponsor ID
- Low volume preparations
- Conditions
- Colon Cleansing for Colonoscopy
- Keywords
- Colon preparation, Colonoscopy, Polyethylene glycol, Sodium Picosulphate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 May 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.
Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon preparation affects the quality of colon cleansing. The study is aimed at comparing the efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor bowel preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium picosulphate/magnesium citrate | Experimental | Drug: sodium picosulphate magnesium citrate |
| low-volume PEG -ascorbic acid | Active comparator | Drug: low-volume PEG -ascorbic acid |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult outpatients
- aged 18-85 years
- undergoing elective colonoscopy
Key exclusion criteria (11 listed)
- previous colon resection
- ileus
- intestinal obstruction
- toxic megacolon
- severe heart failure (New York Heart Association [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: Citrafleet, IBI Lorenzini, Aprilia, ItalyUse of the product in colon cleansing before colonoscopy. Two sachets each containing 10 mg of sodium picosulfate, 3.5 g magnesium oxide and 12.0 g citric acid. The 2 doses are taken diluted in a glass water. | Drug | sodium picosulphate/magnesium citrate |
| low-volume PEG -ascorbic acidAlso: Moviprep, Norgine Ltd, Harefield, UKTHe product is used as colon cleanser before colonoscopy. It is supplied as a powder for oral use, to be reconstituted with 2 L of water and drunk as a solution. It consists of 100.0 g macrogol 3350 plus electrolytes (7.5 g sodium sulphate, 2.7 g sodium chloride, 1.0 g potassium chloride) and 4.7 g ascorbic acid. | Drug | low-volume PEG -ascorbic acid |
Primary outcome
Efficacy of bowel cleansing
Time frame: Within 24 hrs
Assessment of quality of colon cleansing at colonoscopy as achieved by the two study products
2 secondary outcomes
Safety
Time frame: In the 24 hours within assumption of study products
Tolerability
Time frame: Within 12 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 22 May 2012.
Related trials for Colon Cleansing for Colonoscopy
RecruitingPhase 1/2
Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
Bowel Preparation
Not yet recruitingPhase 3
A Study to Evaluate the Safety and Effectiveness of MSP01-T for Bowel Cleansing Before a Colonoscopy
Colonoscopy, Bowel Preparation
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
Ospedale L. Sacco
3 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 and low-volume PEG -ascorbic acid in people with Colon Cleansing for Colonoscopy, run by ASST Fatebenefratelli Sacco at 3 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 11 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 22 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Efficacy of bowel cleansing (time frame: Within 24 hrs). 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 22 May 2012.