A Phase 3 interventional study of Fexofenadine M016455 and Placebo in Rhinitis Seasonal, sponsored by Sanofi. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objectives:
Secondary Objective:
To evaluate the safety of a single dose of fexofenadine hydrochloride 180 mg.
The total study duration per subject is expected to last up to 4.5 months, depending on the timing of the screening visit.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 240 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Fexofenadine, single administration
Drug: Fexofenadine M016455
Placebo, single administration
Drug: Placebo
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Total nasal symptom score (TNSS)
Assessed by measuring change in the area under the curve (AUC) of the TNSS during Period 1 and 2
Time frame: From hour 0 to hour 12 in Period 1 and Period 2
TNSS
Assessed by measuring change in the AUC of the TNSS from hour 2 (planned time of investigational medicinal product administration) to hour 12 in Period 3
Time frame: From hour 2 to hour 12 in Period 3
Total symptom score (TSS)
Assessed by measuring change in the AUC of TSS from hour 2 (planned time of investigational medicinal product administration) to hour 12
Time frame: From hour 2 to hour 12 in Period 3
Individual symptom score
Assessed by measuring the change in AUC of individual symptom score from hour 2 (planned time of investigational medicinal product administration) to hour 12
Time frame: From hour 2 to hour 12 in Period 3
TNSS
Assessed by change in TNSS by time point from hour 2 to hour 12
Time frame: From hour 2 to hour 12 in Period 3
Adverse events
Incidence of adverse events
Time frame: Up to 4.5 months
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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