Need for Bowel PreparationPhase 1/2Prepopik PREANCT01928862

Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy

A Phase 1/2 study testing Prepopik® ½ Sachet x 2 (9-12 years), Prepopik® 1 Sachet x 2 (9-12 years) and Oral polyethylene glycol (PEG) based preparation (9-12 years) in people with Need for Bowel Preparation, run by Ferring Pharmaceuticals at 9 sites in United States.

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

To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy Read more about this study

Who is it for?: Ages 9 to 16 years
Conditions the study is for: Need for Bowel Preparation
What is being tested?: Prepopik® ½ Sachet x 2 (9-12 years), Prepopik® 1 Sachet x 2 (9-12 years) and Oral polyethylene glycol (PEG) based preparation (9-12 years)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 9 sitesUnited States
Study dates: 3 Jun 2014to 16 Mar 2017
Phase: Phase 1/2
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 9 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female, aged 9 years to 16 years, inclusive, being scheduled to undergo elective colonoscopy
Subjects must have had 3 or more spontaneous bowel movements per week for 1 month prior to the colonoscopy
Female subjects of childbearing potential must undergo a pregnancy test at screening and again at randomization

Who cannot join

Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
Hospitalized for inflammatory bowel disease
Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic surgical procedures
Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo obstruction, hypomotility syndrome, colon resection)
Ascites
Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)

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Upper gastrointestinal surgery (gastric resection, gastric banding, gastric bypass)
Significant cardiovascular disease as determined by the investigator
If subject has a history of renal insufficiency, serum creatinine and potassium must be within normal limits
Any clinically significant laboratory value at screening, including pre- existing electrolyte abnormality, based on clinical history
Hypersensitivity to active ingredients

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

John Hopkins
Baltimore, Maryland
University of Alabama
Birmingham, Alabama
Nationwide Children's Hospital
Columbus, Ohio
IU Medical Center / Riley Hospital
Indianapolis, Indiana
Vanderbilt University Medical Center
Nashville, Tennessee
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania
University California San Diego - Rady's Children's Hospital
San Diego, California
Stony Brook Children's
Stony Brook, New York

Other trials in United States

About this study

Official title: A Randomized, Assessor-Blind, Multicenter, Dose-Ranging Study Comparing the Safety and Efficacy of Prepopik® Versus Polyethylene Glycol Preparation (Local Standard of Care) in Children Aged 9 Years to 16 Years

To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy

Conditions: Need for Bowel Preparation
Being tested: Prepopik® ½ Sachet x 2 (9-12 years), Prepopik® 1 Sachet x 2 (9-12 years), Oral polyethylene glycol (PEG) based preparation (9-12 years), Prepopik® 1 Sachet x 2 (13-16 years), Oral polyethylene glycol (PEG) based preparation (13-16 years)

What participants receive

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

Prepopik® ½ Sachet x 2 (9-12 years)Drug
Also called Prepopik®
Prepopik® 1 Sachet x 2 (9-12 years)Drug
Also called Prepopik®
Oral polyethylene glycol (PEG) based preparation (9-12 years)Drug
Prepopik® 1 Sachet x 2 (13-16 years)Drug
Also called Prepopik®
Oral polyethylene glycol (PEG) based preparation (13-16 years)Drug

Study groups in NCT01928862
Study group	Role	What they receive
Prepopik® ½ Sachet x 2 (9-12 years)	Experimental	Prepopik® ½ Sachet x 2 (9-12 years) Receives: Drug: Prepopik® ½ Sachet x 2 (9-12 years)
Prepopik® 1 Sachet x 2 (9-12 years)	Experimental	Prepopik® 1 Sachet x 2 (9-12 years) Receives: Drug: Prepopik® 1 Sachet x 2 (9-12 years)
Oral polyethylene glycol (PEG) based preparation (9-12 years)	Active comparator	Local standard of care Receives: Drug: Oral polyethylene glycol (PEG) based preparation (9-12 years)
Prepopik® 1 Sachet x 2 (13-16 years)	Experimental	Prepopik® 1 Sachet x 2 (13-16 years) Receives: Drug: Prepopik® 1 Sachet x 2 (13-16 years)
Oral polyethylene glycol (PEG) based preparation (13-16 years)	Active comparator	Local standard of care Receives: Drug: Oral polyethylene glycol (PEG) based preparation (13-16 years)

What is being measured

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

Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale
Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
Measured: On the day of colonoscopy

Secondary outcomes (5)

Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant taking part in a clinical trial. Proportion of participants with AE are presented.
Measured: Up to 33 days after colonoscopy
Number of Participants With Abnormal Findings in Laboratory Tests
Proportion of participants with abnormal findings in laboratory tests are presented.
Measured: From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy
Number of Participants With Abnormal Findings in Physical Examination
Complete physical examination was conducted at screening and directed physical examinations at other time-points. Directed physical examinations are presented.
Measured: From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy
Number of Participants Who Took the Assigned Dose for Colon Cleansing
The proportion of participants who took the assigned dose of Prepopik® was assessed.
Measured: Approx. 1 day (From the day before colonoscopy to the day of colonoscopy)
Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"
Subject's Tolerability and Satisfaction Questionnaire consists of three questions. Question (Q)1 was "How easy was it to drink the bowel cleanout medicine?" and Q2 was "How did the bowel cleanout medicine taste?". Q3 had five subparts namely: 1. "How often did your tummy hurt since you started the medicine?" and 2. "How often did you feel fullness in your tummy, since you started the cleanout?" and 3. "How often did you wake up last night" and 4. "How often did you feel sick to your stomach (nausea) since you started the cleanout?' and 5. "How much were you bothered by going to the washroom since you started the cleanout?"
Satisfactory was defined as a response of 1 (Very Easy) or 2 (Easy) on Q1 and a response of 1 (Very Well) or 2 (Well) on Q2.
Tolerable was defined as a response of 1 (Never) or 2 (Rarely) to the five subparts specified in Q3.
Measured: 1 day of colonoscopy

Timeline

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

3 Jun 201416 Mar 2017

First posted27 Aug 2013 (estimated)
Study start3 Jun 2014
Primary completion15 Feb 2017
Study completion16 Mar 2017

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 Need 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01928862
Sponsor's protocol ID: 000103
Acronym: Prepopik PREA
Status last verified: Mar 2018
First submitted: 19 Aug 2013
Last updated: 23 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Assessor-Blind, Multicenter, Dose-Ranging Study Comparing the Safety and Efficacy of Prepopik® Versus Polyethylene Glycol Preparation (Local Standard of Care) in Children Aged 9 Years to 16 Years
ClinicalTrials.gov ID: NCT01928862
Acronym / sponsor ID: Prepopik PREA / 000103
Conditions: Need for Bowel Preparation
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 3 Jun 2014 (actual)
Primary completion: 15 Feb 2017 (actual)
Study completion: 16 Mar 2017 (actual)
First posted: 27 Aug 2013 (estimated)
Results: Posted 23 Apr 2018

Clinical summary

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

To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Prepopik® ½ Sachet x 2 (9-12 years)	Experimental	Drug: Prepopik® ½ Sachet x 2 (9-12 years)Prepopik® ½ Sachet x 2 (9-12 years)
Prepopik® 1 Sachet x 2 (9-12 years)	Experimental	Drug: Prepopik® 1 Sachet x 2 (9-12 years)Prepopik® 1 Sachet x 2 (9-12 years)
Oral polyethylene glycol (PEG) based preparation (9-12 years)	Active comparator	Drug: Oral polyethylene glycol (PEG) based preparation (9-12 years)Local standard of care
Prepopik® 1 Sachet x 2 (13-16 years)	Experimental	Drug: Prepopik® 1 Sachet x 2 (13-16 years)Prepopik® 1 Sachet x 2 (13-16 years)
Oral polyethylene glycol (PEG) based preparation (13-16 years)	Active comparator	Drug: Oral polyethylene glycol (PEG) based preparation (13-16 years)Local standard of care

Who may qualify

Ages: 9 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male or female, aged 9 years to 16 years, inclusive, being scheduled to undergo elective colonoscopy
Subjects must have had 3 or more spontaneous bowel movements per week for 1 month prior to the colonoscopy
Female subjects of childbearing potential must undergo a pregnancy test at screening and again at randomization

Key exclusion criteria (11 listed)

Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
Hospitalized for inflammatory bowel disease
Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic surgical procedures
Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo obstruction, hypomotility syndrome, colon resection)
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
Prepopik® ½ Sachet x 2 (9-12 years)Also: Prepopik®	Drug	Prepopik® ½ Sachet x 2 (9-12 years)
Prepopik® 1 Sachet x 2 (9-12 years)Also: Prepopik®	Drug	Prepopik® 1 Sachet x 2 (9-12 years)
Oral polyethylene glycol (PEG) based preparation (9-12 years)	Drug	Oral polyethylene glycol (PEG) based preparation (9-12 years)
Prepopik® 1 Sachet x 2 (13-16 years)Also: Prepopik®	Drug	Prepopik® 1 Sachet x 2 (13-16 years)
Oral polyethylene glycol (PEG) based preparation (13-16 years)	Drug	Oral polyethylene glycol (PEG) based preparation (13-16 years)

Primary outcome

Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale
Time frame: On the day of colonoscopy
Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.

5 secondary outcomes

Number of Participants With Adverse Events
Time frame: Up to 33 days after colonoscopy
Number of Participants With Abnormal Findings in Laboratory Tests
Time frame: From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy
Number of Participants With Abnormal Findings in Physical Examination
Time frame: From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy
Number of Participants Who Took the Assigned Dose for Colon Cleansing
Time frame: Approx. 1 day (From the day before colonoscopy to the day of colonoscopy)
Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"
Time frame: 1 day of colonoscopy

Results and safety

Results posted to the registry on 23 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prepopik® ½ Sachet x 2 (9-12 Years)	16	15
Prepopik® 1 Sachet x 2 (9-12 Years)	16	16
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)	16	16
Prepopik® 1 Sachet x 2 (13-16 Years)	16	16
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)	14	13

Primary outcome: Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale

Time frame: On the day of colonoscopy. Number (90% Confidence Interval). Unit: percentage of participants

Measure	Prepopik® ½ Sachet x 2 (9-12 Years) n = 16	Prepopik® 1 Sachet x 2 (9-12 Years) n = 16	Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years) n = 16	Prepopik® 1 Sachet x 2 (13-16 Years) n = 16	Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years) n = 14
Value	50 (27.9 to 72.1)	87.5 (65.6 to 97.7)	81.3 (58.3 to 94.7)	81.3 (58.3 to 94.7)	85.7 (61.5 to 97.4)

Prepopik® ½ Sachet x 2 (9-12 Years) vs Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years): Treatment difference: -31.3 (90% CI -58.8 to 0.8)
Prepopik® 1 Sachet x 2 (9-12 Years) vs Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years): Treatment Difference: 6.3 (90% CI -25.3 to 36.9)
Prepopik® 1 Sachet x 2 (13-16 Years) vs Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years): Treatment Difference: -4.5 (90% CI -33.5 to 26.3)

Population analysed: The primary efficacy analysis was based on the intention-to-treat (ITT) analysis set, which included all participants who were randomized.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prepopik® ½ Sachet x 2 (9-12 Years)	0 of 15 (0%)	8 of 15 (53.3%)	0 of 15
Prepopik® 1 Sachet x 2 (9-12 Years)	0 of 17 (0%)	5 of 17 (29.4%)	0 of 17
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)	0 of 15 (0%)	6 of 15 (40%)	0 of 15
Prepopik® 1 Sachet x 2 (13-16 Years)	0 of 16 (0%)	10 of 16 (62.5%)	0 of 16
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12

Limitations and caveats (from the sponsor): None reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Apr 2018). 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?

Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale (time frame: On the day of colonoscopy). 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 NCT01928862.

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 Apr 2018.