Bowel CleansingPhase 3OPTIMANCT02239692

A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy

A Phase 3 study testing PICOPREP in people with Bowel Cleansing, run by Ferring Pharmaceuticals at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bowel Cleansing
What is being tested?: PICOPREP
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 204 participants
Where: 3 sitesin 3 countries
Study dates: Nov 2014to Jun 2015
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, 18 years of age or above, being scheduled to undergo elective colonoscopy
Subjects must have had more than or equal to 3 spontaneous bowel movements (i.e. without use of any laxative within 24 hours before the bowel movement, with the exception for bulk-forming laxatives (ATC code A06AC)) per week for one month prior to the colonoscopy

Who cannot join

Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures
Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome)
Ascites
Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)

Show all 15Show fewer

Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
Severely reduced renal function (Glomerular filtration rate (GFR) <30 (mL/min/1.73 m2))
The subject is a pregnant (positive urine pregnancy test at Visit 1 or Visit 2) woman. Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who do not agree to use one of the following methods of birth control from the day of signing the Informed Consent Form until End of Trial Visit are excluded:
Transdermal patch
Hormonal contraception (i.e., oral, implant, or injectable contraceptive)
Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.)
Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy
Sexual abstinence
The subject is a breast-feeding or lactating woman

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

France1 site

Ed Herriot Hopital (there may be other sites in this country)
Lyon

Other trials in France

Germany1 site

Gastroenterologie am Bayerischen Platz (there may be other sites in this country)
Berlin

Other trials in Germany

Netherlands1 site

Medisch Centrum Alkmaar (there may be other sites in this country)
Alkmaar

Other trials in Netherlands

About this study

Official title: A Randomised, Assessor-blinded, Multi-centre Trial Comparing the Efficacy, Safety and Tolerability of the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy

Conditions: Bowel Cleansing
Being tested: PICOPREP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PICOPREPDrug
Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution

Study groups in NCT02239692
Study group	Role	What they receive
PICOPREP day-before dosing schedule	Active comparator	Both doses administered the day before colonoscopy. Receives: Drug: PICOPREP
PICOPREP tailored dosing schedule	Experimental	First dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy. Receives: Drug: PICOPREP

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale
Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
Measured: Day 1 (day of colonoscopy)
Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale
Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
Measured: Day 1 (day of colonoscopy)

Secondary outcomes (4)

Ascending Colon Cleansing Responder Status (ITT)
Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.
Measured: Day 1 (day of colonoscopy)
Frequency and Intensity of Adverse Events
Measured: From baseline (screening) up to day 10 after colonoscopy
Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)
Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).
Measured: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)
Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)
Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.
Measured: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Jun 2015

First posted15 Sep 2014 (estimated)
Study startNov 2014
Primary completionJun 2015
Study completionJun 2015

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bowel 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 3
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02239692
Sponsor's protocol ID: 000121
Other IDs: 2014-001062-10, 2014
Acronym: OPTIMA
Status last verified: May 2016
First submitted: 9 Sep 2014
Last updated: 23 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kiesslich R, Schubert S, Mross M, Klugmann T, Klemt-Kropp M, Behnken I, Bonnaud G, Keulen E, Groenen M, Blaker M, Ponchon T, Landry W, Stoltenberg M. Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study. Endosc Int Open. 2017 Apr;5(4):E282-E290. doi: 10.1055/s-0043-102433.
PubMed 28393103

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bowel Cleansing trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Assessor-blinded, Multi-centre Trial Comparing the Efficacy, Safety and Tolerability of the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy
ClinicalTrials.gov ID: NCT02239692
Acronym / sponsor ID: OPTIMA / 000121
Conditions: Bowel Cleansing
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 15 Sep 2014 (estimated)
Results: Posted 23 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PICOPREP day-before dosing schedule	Active comparator	Drug: PICOPREPBoth doses administered the day before colonoscopy.
PICOPREP tailored dosing schedule	Experimental	Drug: PICOPREPFirst dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female, 18 years of age or above, being scheduled to undergo elective colonoscopy
Subjects must have had more than or equal to 3 spontaneous bowel movements (i.e. without use of any laxative within 24 hours before the bowel movement, with the exception for bulk-forming laxatives (ATC code A06AC)) per week for one month prior to the colonoscopy

Key exclusion criteria (15 listed)

Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures
Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome)
Ascites

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
PICOPREPSodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	Drug	PICOPREP day-before dosing schedule, PICOPREP tailored dosing schedule

Primary outcome

Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale
Time frame: Day 1 (day of colonoscopy)
Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale
Time frame: Day 1 (day of colonoscopy)
Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).

4 secondary outcomes

Ascending Colon Cleansing Responder Status (ITT)
Time frame: Day 1 (day of colonoscopy)
Frequency and Intensity of Adverse Events
Time frame: From baseline (screening) up to day 10 after colonoscopy
Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)
Time frame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)
Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)
Time frame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)

Results and safety

Results posted to the registry on 23 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PICOPREP Day-before Dosing Schedule	73	67
PICOPREP Tailored Dosing Schedule	131	118

Primary outcome: Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale

Time frame: Day 1 (day of colonoscopy). Mean (Standard Deviation). Unit: score on a scale

Measure	PICOPREP Day-before Dosing Schedule n = 73	PICOPREP Tailored Dosing Schedule n = 131
Value	8.2 (3.54)	4.2 (3.75)

PICOPREP Day-before Dosing Schedule vs PICOPREP Tailored Dosing Schedule: Adjusted estimated mean difference: -3.93 (95% CI -4.99 to -2.87), p <0.0001, ANCOVA

Population analysed: The ITT analysis set consisted of all randomized subjects.

Primary outcome: Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale

Time frame: Day 1 (day of colonoscopy). Mean (Standard Deviation). Unit: score on a scale

Measure	PICOPREP Day-before Dosing Schedule n = 66	PICOPREP Tailored Dosing Schedule n = 120
Value	8.1 (3.38)	3.7 (3.14)

PICOPREP Day-before Dosing Schedule vs PICOPREP Tailored Dosing Schedule: Adjusted estimated mean difference: -4.38 (95% CI -5.34 to -3.41), p <0.0001, ANCOVA

Population analysed: The per-protocol (PP) analysis set consisted of all the subjects included in ITT analysis set, but excluding subjects with major protocol deviations (18 subjects) that would impact efficacy analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PICOPREP Day-before Dosing Schedule	0 of 70 (0%)	4 of 70 (5.7%)	Not reported
PICOPREP Tailored Dosing Schedule	1 of 125 (0.8%)	14 of 125 (11.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28393103Kiesslich R, Schubert S, Mross M, Klugmann T, Klemt-Kropp M, Behnken I, Bonnaud G, Keulen E, Groenen M, Blaker M, Ponchon T, Landry W, Stoltenberg M. Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study. Endosc Int Open. 2017 Apr;5(4):E282-E290. doi: 10.1055/s-0043-102433.

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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

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PICOPREP in people with Bowel Cleansing, run by Ferring Pharmaceuticals at 3 sites in 3 countries.

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 2 inclusion and 15 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 23 Jun 2016. 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 France, Germany, Netherlands. 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 23 Jun 2016). 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?

Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale (time frame: Day 1 (day of colonoscopy)). The study lists 2 primary outcomes in all. 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 NCT02239692, 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 23 Jun 2016.