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NCT03381196 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
A Phase 3 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 553
- Enrollment target
NCT03381196: Clinical Trial Phase 3 study, sponsored by Janssen Research & Development.
NCT03381196 is a Phase 3 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 553 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03381196, a Phase 3 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 553 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
Primary Outcome
The Flu-iiQ is a PRO that measures influenza symptom intensity (none, mild, moderate, or severe) on a 4 point Likert response rating scale ranging from 0 to 3, where "0" represents the absence of symptom and "3" represents the severe symptom. The resolution of influenza-related symptoms is defined as the beginning of the 24-hour period that 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to p
Interventions
- DRUG Placebo
- DRUG Pimodivir 600 mg
- OTHER SOC Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 553 participants |
| Start Date | 2018-01-21 |
| Est. Completion | 2020-08-24 |
| Phase | Phase 3 |
Why NCT03381196 stopped before completion
NCT03381196 is an interventional study that assigns participants to a tested intervention. The registered 553 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 (28% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03381196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03381196 about?
NCT03381196 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications". The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
What is the current status of trial NCT03381196?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 553 participants. The study started on 2018-01-21. Estimated completion is 2020-08-24.
What interventions are being tested in trial NCT03381196?
The interventions under investigation include: Placebo (DRUG), Pimodivir 600 mg (DRUG), SOC Treatment (OTHER).
Who is sponsoring clinical trial NCT03381196?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03381196's enrollment target sits among peer trials
553 678th of 2000 higher than 1,323 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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