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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 is a Phase 3 study that has completed, run by Astellas Pharma Europe B.V.. The registered enrollment target is 148 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02218372
The ClinicalTrials.gov registry entry for NCT02218372 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Europe B.V., which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fidaxomicin oral suspension is the first listed.
NCT02218372 reports 0 study locations.
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.
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