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NCT01928862 · ClinicalTrials.gov registry record · Phase 1
Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy
A Phase 1 study of Need for Bowel Preparation, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
- 9
- Study locations
NCT01928862: Completed Phase 1 study of Need for Bowel Preparation, sponsored by Ferring Pharmaceuticals.
NCT01928862 is a Phase 1 study of Need for Bowel Preparation that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928862, a Phase 1 study of Need for Bowel Preparation, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
- 9
- Study locations
Study Summary
To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy
Primary Outcome
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). T
Conditions Studied
Interventions
- DRUG 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)
Study Locations (9)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh - Pittsburgh
Alabama
- University of Alabama - Birmingham
California
- University California San Diego - Rady's Children's Hospital - San Diego
Indiana
- IU Medical Center / Riley Hospital - Indianapolis
Maryland
- John Hopkins - Baltimore
New York
- Stony Brook Children's - Stony Brook
Ohio
- Nationwide Children's Hospital - Columbus
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2014-06-03 |
| Est. Completion | 2017-03-16 |
| Phase | Phase 1 |
What the finished NCT01928862 record still lists
NCT01928862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Need for Bowel Preparation appearing as the primary indexed condition, and to 5 interventions - of which Prepopik® ½ Sachet x 2 (9-12 years) is the first listed.
NCT01928862 lists 9 locations in 8 states (Pennsylvania, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT01928862 about?
NCT01928862 is a clinical study titled "Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy". To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy
What is the current status of trial NCT01928862?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2014-06-03. Estimated completion is 2017-03-16.
What conditions does trial NCT01928862 study?
This clinical trial studies the following conditions: Need for Bowel Preparation.
What interventions are being tested in trial NCT01928862?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT01928862?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01928862 being conducted?
This trial has 9 study locations across Alabama, California, Indiana, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01928862's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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