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NCT02218372 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
A Phase 3 study, sponsored by Astellas Pharma Europe B.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 148
- Enrollment target
NCT02218372: Completed Phase 3 study, sponsored by Astellas Pharma Europe B.V..
NCT02218372 is a Phase 3 study that has completed, run by Astellas Pharma Europe B.V.. The registered enrollment target is 148 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02218372, a Phase 3 study, has completed, sponsored by Astellas Pharma Europe B.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 148 participants
- Enrollment target
Study Summary
The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.
Primary Outcome
Initial clinical response (ICR) for ages from birth to \< 2 years was defined as absence of watery diarrhea for 2 consecutive treatment days, remaining well until study drug discontinuation. ICR for ages ≥ 2 years to \< 18 years was defined as improvement in number and character of bowel movements as determined by \< 3 unformed bowel movements (UBMs) per day for 2 consecutive treatment days, remaining well until study drug discontinuation. CCR was defined for both age groups as not requiring fur
Interventions
- DRUG Fidaxomicin oral suspension
- DRUG Fidaxomicin tablets
- DRUG Vancomycin oral liquid
- DRUG Vancomycin capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2015-01-09 |
| Est. Completion | 2018-03-07 |
| Phase | Phase 3 |
What the finished NCT02218372 record still lists
NCT02218372 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 4 interventions - of which Fidaxomicin oral suspension is the first listed.
NCT02218372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02218372 about?
NCT02218372 is a clinical study titled "A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)". The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and ...
What is the current status of trial NCT02218372?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 148 participants. The study started on 2015-01-09. Estimated completion is 2018-03-07.
What interventions are being tested in trial NCT02218372?
The interventions under investigation include: Fidaxomicin oral suspension (DRUG), Fidaxomicin tablets (DRUG), Vancomycin oral liquid (DRUG), Vancomycin capsules (DRUG).
Who is sponsoring clinical trial NCT02218372?
This trial is sponsored by Astellas Pharma Europe B.V., which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02218372's enrollment target sits among peer trials
148 1547th of 2000 higher than 451 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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