Bowel PreparationPhase 4CLEAR PREPNCT02386449
A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy
A Phase 4 study testing sodium picosulfate, magnesium oxide and citric acid (Picoprep®), mannitol and Bisacodyl in people with Bowel Preparation, run by Ferring Pharmaceuticals at 1 site in Brazil.
Trial summary
This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- sodium picosulfate, magnesium oxide and citric acid (Picoprep®), mannitol and Bisacodyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Dec 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men or women aged 18 to 60 years
- Subjects scheduled for an elective colonoscopy
- Women of child-bearing potential using at least one highly effective contraceptive method
- Subjects able to understand all instructions
- Informed consent signed
Who cannot join
- Hypersensitivity to active ingredients
- Female participants pregnant or with a positive blood pregnancy test
- Acute surgical abdomen
- Previous colorectal surgery
- Gastrointestinal (GI) surgery
- GI diseases, active inflammatory bowel disease, colon disease
Show all 9Show fewer
- Ascites/hepatic cirrhosis, cardiac disease, advanced pulmonary or renal disease
- Use of laxatives or antidiarrheal agents 72 hours prior to screening
- Significant alterations in laboratory values or other diseases that could interfere with the results
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (there may be other sites in this country)
São Paulo
About this study
Official title: A Randomized, Controlled, Parallel Group, Assessor-Blinded Study To Compare The Efficacy, Tolerability, And Safety Of Oral Sodium Picosulfate (PicoPrep®) Versus Oral Mannitol and Bisacodyl, For Colon Cleansing In Colonoscopy Preparation Of Adult Outpatients
This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.
- Conditions
- Bowel Preparation
- Being tested
- sodium picosulfate, magnesium oxide and citric acid (Picoprep®), mannitol, Bisacodyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium picosulfate, magnesium oxide and citric acid (Picoprep®)Drug
mannitolDrug
BisacodylDrug
| Study group | Role | What they receive |
|---|---|---|
| Picoprep | Experimental | sodium picosulfate, magnesium oxide and citric acid Receives: Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®) |
| Mannitol and Bisacodyl | Active comparator | Not described Receives: Drug: mannitol; Drug: Bisacodyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects classified as success (Aronchick scale)
Defined as excellent or good according to the Aronchick scale
Measured: At visit 2 (day 1 of colonoscopy)
Secondary outcomes (3)
Percentage of subjects classified as success (Ottawa scale)
Defined as excellent, good or fair according to the Ottawa scale
Measured: At visit 2 (day 1 of colonoscopy)
Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire)
As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire
Measured: At visit 2 (day 1 of colonoscopy)
Subject satisfaction (Likert scale)
As assessed by a subject survey using a 3 point Likert scale
Measured: At visit 2 (day 1 of colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386449
- Sponsor's protocol ID
- 000180
- Acronym
- CLEAR PREP
- Status last verified
- Jan 2016
- First submitted
- 6 Mar 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Parallel Group, Assessor-Blinded Study To Compare The Efficacy, Tolerability, And Safety Of Oral Sodium Picosulfate (PicoPrep®) Versus Oral Mannitol and Bisacodyl, For Colon Cleansing In Colonoscopy Preparation Of Adult Outpatients
- ClinicalTrials.gov ID
- NCT02386449
- Acronym / sponsor ID
- CLEAR PREP / 000180
- Conditions
- Bowel Preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Mar 2015 (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 a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Picoprep | Experimental | Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®)sodium picosulfate, magnesium oxide and citric acid |
| Mannitol and Bisacodyl | Active comparator | Drug: mannitol, Drug: Bisacodyl |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men or women aged 18 to 60 years
- Subjects scheduled for an elective colonoscopy
- Women of child-bearing potential using at least one highly effective contraceptive method
- Subjects able to understand all instructions
- Informed consent signed
Key exclusion criteria (9 listed)
- Hypersensitivity to active ingredients
- Female participants pregnant or with a positive blood pregnancy test
- Acute surgical abdomen
- Previous colorectal surgery
- Gastrointestinal (GI) surgery
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 picosulfate, magnesium oxide and citric acid (Picoprep®) | Drug | Picoprep |
| mannitol | Drug | Mannitol and Bisacodyl |
| Bisacodyl | Drug | Mannitol and Bisacodyl |
Primary outcome
Percentage of subjects classified as success (Aronchick scale)
Time frame: At visit 2 (day 1 of colonoscopy)
Defined as excellent or good according to the Aronchick scale
3 secondary outcomes
Percentage of subjects classified as success (Ottawa scale)
Time frame: At visit 2 (day 1 of colonoscopy)
Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire)
Time frame: At visit 2 (day 1 of colonoscopy)
Subject satisfaction (Likert scale)
Time frame: At visit 2 (day 1 of colonoscopy)
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 12 Jan 2016.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site 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 picosulfate, magnesium oxide and citric acid (Picoprep®), mannitol and Bisacodyl in people with Bowel Preparation, run by Ferring Pharmaceuticals at 1 site in Brazil.
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 5 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 12 Jan 2016. 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 Brazil. 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?
Percentage of subjects classified as success (Aronchick scale) (time frame: At visit 2 (day 1 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 12 Jan 2016.