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NCT04113382 · ClinicalTrials.gov registry record · Phase 1
Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
A Phase 1 study of Bowel Preparation, sponsored by Ferring Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 5
- Study locations
NCT04113382: Recruiting Phase 1 study of Bowel Preparation, sponsored by Ferring Pharmaceuticals.
NCT04113382 is a Phase 1 study of Bowel Preparation that is actively recruiting participants, run by Ferring Pharmaceuticals. The registered enrollment target is 30 participants, below the 1,050-participant average among 3 other Bowel Preparation trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04113382, a Phase 1 study of Bowel Preparation, is actively recruiting participants, sponsored by Ferring Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 5
- Study locations
Study Summary
Bowel preparation for pediatric colonoscopy.
Primary Outcome
The efficacy of overall colon cleansing in terms of responders will be graded by a blinded endoscopist using the Modified Aronchick Scale. It 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/o
Conditions Studied
Interventions
- DRUG CLENPIQ
- DRUG MIRALAX
Study Locations (5)
Maryland
- Ferring Investigational Site - Baltimore
- Ferring Investigational Site - Baltimore
Alabama
- Ferring Investigational Site - Mobile
California
- Ferring Investigational Site - San Diego
New York
- Ferring Investigational Site - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-06-23 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What NCT04113382 shows while recruiting
NCT04113382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,050-participant average among 3 other Bowel Preparation trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Bowel Preparation appearing as the primary indexed condition, and to 2 interventions - of which CLENPIQ is the first listed.
NCT04113382 lists 5 locations in 4 states (Maryland, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT04113382 about?
NCT04113382 is a clinical study titled "Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy". Bowel preparation for pediatric colonoscopy.
What is the current status of trial NCT04113382?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-06-23. Estimated completion is 2026-03.
What conditions does trial NCT04113382 study?
This clinical trial studies the following conditions: Bowel Preparation.
What interventions are being tested in trial NCT04113382?
The interventions under investigation include: CLENPIQ (DRUG), MIRALAX (DRUG).
Who is sponsoring clinical trial NCT04113382?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04113382 being conducted?
This trial has 5 study locations across Alabama, California, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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