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

Ferring

Status and phase: Completed; Phase 2; Phase 1

Conditions: Need for Bowel Preparation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01928862

000103

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 9 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 5 patient groups

Prepopik® ½ Sachet x 2 (9-12 years)

Experimental group

Description:

Prepopik® ½ Sachet x 2 (9-12 years)

Treatment:

Drug: Prepopik® ½ Sachet x 2 (9-12 years)

Prepopik® 1 Sachet x 2 (9-12 years)

Experimental group

Description:

Prepopik® 1 Sachet x 2 (9-12 years)

Treatment:

Drug: Prepopik® 1 Sachet x 2 (9-12 years)

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

Active Comparator group

Description:

Local standard of care

Treatment:

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

Prepopik® 1 Sachet x 2 (13-16 years)

Experimental group

Description:

Prepopik® 1 Sachet x 2 (13-16 years)

Treatment:

Drug: Prepopik® 1 Sachet x 2 (13-16 years)

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

Active Comparator group

Description:

Local standard of care

Treatment:

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