ColonoscopyPhase 3NCT01356407
Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy
A Phase 3 study testing PICOPREP and PEG-ELS in people with Colonoscopy, run by Ferring Pharmaceuticals at 7 sites in China.
Trial summary
Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- PICOPREP and PEG-ELS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 7 sitesChina
- Study dates
- Jan 2011to Jul 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures
- Chinese citizen
- Males or females aged between 18 and 70 years inclusive
- Patients scheduled for colonoscopy
- Patients who are able to observe instructions given during the study, and are able to complete the entire study procedure
Who cannot join
- Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control
- Taking concomitant lithium
- Allergy to any ingredient in the study medication
- History of gastrointestinal diseases (active ulcers, gastric outlet obstruction, gastric retention, intestinal obstruction)
- Colon diseases (toxic megacolon, toxic colitis, idiopathic intestinal pseudo-obstruction, gastric retention, intestinal obstruction, lazy bowel syndrome) at screening
- Active (acute/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
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- Acute abdominal symptoms (acute intestinal obstruction, intestinal perforation, diverticulitis or appendicitis)
- Ascites
- History of surgery in upper gastrointestinal tract (gastrectomy, gastric banding, gastric bypass surgery)
- History of colorectal surgery (excluding appendectomy, hemorrhoidectomy and endoscopic surgery)
- Uncontrolled angina and/or myocardial infarction, congestive heart failure, or uncontrolled hypertension within 3 months prior randomisation
- Severe liver damage
- Kidney function impairment
- Diabetics currently on insulin treatment
- Having participated in any other clinical trial during the 3 month prior recruitment
- Patients who are unable to act in a legal capacity, unable to meet or perform study requirements
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Nanfang Hospital, Southern Medical University
Guangzhou
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
Drum Tower Hospital
Nanjing
Changhai Hospital, The Second Military Medical University
Shanghai
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Huazhong Technological University Tongji Medical College Affiliated Union Hospital
Wuhan
About this study
Official title: A Multi-center, Randomized, Single-blind Clinical Study of the Efficacy and Safety of PICOPREP and Polyethylene Glycol-electrolyte 4000 Powder for Oral Solution (PEG-ELS) for the Bowel Preparation Prior Colonoscopy
Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.
- Conditions
- Colonoscopy
- Being tested
- PICOPREP, PEG-ELS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICOPREPDrug
PEG-ELSDrug
| Study group | Role | What they receive |
|---|---|---|
| PICOPREP | Experimental | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy. Receives: Drug: PICOPREP |
| PEG-ELS | Active comparator | PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination. Receives: Drug: PEG-ELS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation
The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)
Measured: day 2
Secondary outcomes (5)
Patient Response to Acceptability and Tolerability Questionnaire
On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)).
Measured: Day 2
Ottawa Scale Score by Colon Segment
Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score
Measured: Day 2
Percentage of Successful Completion of Colonoscopy
An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)
Measured: Day 2
Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)
At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality "adequate for clinical diagnostic purposes" (Y/N). The total Ottawa Scale scores was correlated with 'adequate' or 'inadequate' quality of bowel preparation for clinical diagnostic purposes
Measured: Day 2
Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation
The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 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
- NCT01356407
- Sponsor's protocol ID
- FE999169 CS02
- Status last verified
- Dec 2012
- First submitted
- 18 May 2011
- Last updated
- 28 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Single-blind Clinical Study of the Efficacy and Safety of PICOPREP and Polyethylene Glycol-electrolyte 4000 Powder for Oral Solution (PEG-ELS) for the Bowel Preparation Prior Colonoscopy
- ClinicalTrials.gov ID
- NCT01356407
- Acronym / sponsor ID
- FE999169 CS02
- Conditions
- Colonoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 May 2011 (estimated)
- Results
- Posted 28 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICOPREP | Experimental | Drug: PICOPREP"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy. |
| PEG-ELS | Active comparator | Drug: PEG-ELSPEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures
- Chinese citizen
- Males or females aged between 18 and 70 years inclusive
- Patients scheduled for colonoscopy
- Patients who are able to observe instructions given during the study, and are able to complete the entire study procedure
Key exclusion criteria (16 listed)
- Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control
- Taking concomitant lithium
- Allergy to any ingredient in the study medication
- History of gastrointestinal diseases (active ulcers, gastric outlet obstruction, gastric retention, intestinal obstruction)
- Colon diseases (toxic megacolon, toxic colitis, idiopathic intestinal pseudo-obstruction, gastric retention, intestinal obstruction, lazy bowel syndrome) at screening
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 |
|---|---|---|
| PICOPREP | Drug | PICOPREP |
| PEG-ELS | Drug | PEG-ELS |
Primary outcome
The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation
Time frame: day 2
The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)
5 secondary outcomes
Patient Response to Acceptability and Tolerability Questionnaire
Time frame: Day 2
Ottawa Scale Score by Colon Segment
Time frame: Day 2
Percentage of Successful Completion of Colonoscopy
Time frame: Day 2
Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)
Time frame: Day 2
Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation
Time frame: Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PICOPREP and PEG-ELS in people with Colonoscopy, run by Ferring Pharmaceuticals at 7 sites in China.
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 16 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 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation (time frame: day 2). 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 28 Jan 2013.