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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-03

Study Completion Date

2017-03-16

Brief Summary

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

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Detailed Description

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Conditions

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Need for Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prepopik® ½ Sachet x 2 (9-12 years)

Group Type EXPERIMENTAL

Prepopik® ½ Sachet x 2 (9-12 years)

Intervention Type DRUG

Prepopik® 1 Sachet x 2 (9-12 years)

Group Type EXPERIMENTAL

Prepopik® 1 Sachet x 2 (9-12 years)

Intervention Type DRUG

Oral polyethylene glycol (PEG) based preparation (9-12 years)

Local standard of care

Group Type ACTIVE_COMPARATOR

Oral polyethylene glycol (PEG) based preparation (9-12 years)

Intervention Type DRUG

Prepopik® 1 Sachet x 2 (13-16 years)

Group Type EXPERIMENTAL

Prepopik® 1 Sachet x 2 (13-16 years)

Intervention Type DRUG

Oral polyethylene glycol (PEG) based preparation (13-16 years)

Local standard of care

Group Type ACTIVE_COMPARATOR

Oral polyethylene glycol (PEG) based preparation (13-16 years)

Intervention Type DRUG

Interventions

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Prepopik® ½ Sachet x 2 (9-12 years)

Intervention Type DRUG

Prepopik® 1 Sachet x 2 (9-12 years)

Intervention Type DRUG

Oral polyethylene glycol (PEG) based preparation (9-12 years)

Intervention Type DRUG

Prepopik® 1 Sachet x 2 (13-16 years)

Intervention Type DRUG

Oral polyethylene glycol (PEG) based preparation (13-16 years)

Intervention Type DRUG

Other Intervention Names

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Prepopik® Prepopik® Prepopik®

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
* 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

Minimum Eligible Age

9 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No