Phase 2
N=78
Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy
Need for Bowel Preparation
Bottom Line
View on ClinicalTrials.gov: NCT01928862 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale — 50; 87.5; 81.3; 81.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prepopik® ½ Sachet x 2 (9-12 years) (Drug); Prepopik® 1 Sachet x 2 (9-12 years) (Drug); Oral polyethylene glycol (PEG) based preparation (9-12 years) (Drug); Prepopik® 1 Sachet x 2 (13-16 years) (Drug); Oral polyethylene glycol (PEG) based preparation (13-16 years) (Drug)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale |
50; 87.5; 81.3; 81.3; 85.7 | — |
| SECONDARY Number of Participants With Adverse Events |
8; 5; 6; 10; 11 | — |
| SECONDARY Number of Participants With Abnormal Findings in Laboratory Tests |
2; 2; 4; 1; 1; 4 | — |
| SECONDARY Number of Participants With Abnormal Findings in Physical Examination |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Took the Assigned Dose for Colon Cleansing |
15; 17; 15; 16; 12; 14 | — |
| SECONDARY Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire" |
9; 6; 2; 8; 4; 4 | — |
Summary
To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01928862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.