Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02469298 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT02469298 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 45 participants.
The verdict
NCT02469298, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm outpatient study evaluating the safety, tolerability and clinical effect of danirixin or danirixin + oseltamivir combination in comparison to placebo or oseltamivir twice daily for 5 days in otherwise healthy adults with laboratory confirmed influenza infection. Danirixin is a selective and reversible C-X-C Chemokine Receptor 2 (CXCR2) antagonist that inhibits neutrophil transmigration and activation to areas of inflammation. The study endpoints are intended to test the hypothesis that inhibition of neutrophil activation by approximately 50-60% (as previously measured by cluster of differentiation \[CD11b\] expression in response to chemokine \[C-X-C motif\] ligand 1 \[CXCL1\] stimulation ex vivo in human studies) will not impact safety parameters or worsen clinical manifestations of disease, disease-related events of interest, or viral load, and may possibly improve these parameters when administered within 48 hours of symptom onset. The aim of this exploratory study is to obtain data on the safety, tolerability and clinical effect of GSK1325756 (danirixin \[DNX\]) alone or in combination with oseltamivir (OSV) in otherwise healthy adults with acute, uncomplicated influenza prior to future evaluation in hospitalized patients with complicated influenza. The primary objective is to assess safety and tolerability of DNX with and without a neuraminidase inhibitor through the evaluation of AEs, SAEs, clinical laboratory tests, vital signs, and electrocardiogram (ECG) parameters. Safety assessments will also include an assessment of disease related events (DREs) of interest and associated antibiotic use. The Influenza Intensity and Impact Questionnaire (FluiiQ™) will be used in the study to document patient reported outcomes (PROs). The screening visit in Australia will be composed of a pre-screen for influenza infection with an influenza rapid antigen test followed by a screen for the rem
Interventions
- DRUG Oseltamivir Phosphate
- DRUG GSK1325756 (Danirixin)
- DRUG Placebo To Match GSK1325756
- DRUG Placebo To Match Oseltamivir Phosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2015-06-01 |
| Est. Completion | 2016-04-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02469298
The ClinicalTrials.gov registry entry for NCT02469298 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Oseltamivir Phosphate is the first listed.
NCT02469298 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02469298 about?
NCT02469298 is a clinical study titled "Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza". Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm outpatient study evaluating the safety, tolerability and clinical effect of danirixin or danirixin + oseltamivir combination in comparison to placebo or oseltamivir twice daily for 5 days in otherwise healthy adults w...
What is the current status of trial NCT02469298?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2015-06-01. Estimated completion is 2016-04-25.
What interventions are being tested in trial NCT02469298?
The interventions under investigation include: Oseltamivir Phosphate (DRUG), GSK1325756 (Danirixin) (DRUG), Placebo To Match GSK1325756 (DRUG), Placebo To Match Oseltamivir Phosphate (DRUG).
Who is sponsoring clinical trial NCT02469298?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.