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xylo+dex

Phase 3

Nasal Congestion | Small molecule | ENT |Johnson & Johnson|Trials Updated: Oct 18, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

xylo+dex clinical trials

xylo+dex · 1 trial · 1 indication

Phase 3 1
NCT03439436A Study to Compare Two Formulations of Xylometazoline/Dexpanthenol Nasal Spray for the Treatment of Nasal Congestion.Nasal Congestion
COMPLETED140 Analytics
PHASE3COMPLETED
A Study to Compare Two Formulations of Xylometazoline/Dexpanthenol Nasal Spray for the Treatment of Nasal Congestion.
Nasal CongestionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in self-assessment of nasal congestion after 72 hours of treatment.
After 72 hours of treatment.

Secondary Endpoints

Change from baseline in self-assessment of nasal congestion at 24 and 120 hours post dose.
At 24 and 120 hours post dose.
Change from baseline in self-assessment of rhinorrhea after 24 hours, 72 and 120 hours post dose.
At 24 hours, 72 and 120 hours post dose
Assessment of nasal crusting after 24 hours, 72 hours and 120 hours post dose.
At 24 hours, 72 hours and 120 hours post dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
xylo+dex nasal spray (0.1 mg+5 mg/dose)EXPERIMENTALXylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.
NasicACTIVE_COMPARATORXylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.

Interventions

NameTypeDescription
xylo+dex nasal spray (0.1 mg+5 mg/dose)DRUGXylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.
NasicDRUGXylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria * Subjects of 18 years of age or older; * Subjects suffering from nasal congestion with a clinical diagnosis of acute upper respiratory tract infection where symptoms of nasal congestion have persisted for minimum of 3 hours and maximum of 36 hours; * Body mass index (BMI) 18.5 t...

Countries:Russia
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Frequently asked questions about xylo+dex

What is xylo+dex used for?

xylo+dex is a nasal spray combination product being developed for the treatment of nasal congestion. It combines xylometazoline and dexpanthenol in a fixed-dose formulation. The program is in Phase 3 development, and the single registered trial in the program has been completed.

Who makes xylo+dex?

xylo+dex is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The product is a small molecule nasal spray combination of xylometazoline and dexpanthenol, studied for nasal congestion.

What phase is xylo+dex in?

xylo+dex is in Phase 3 development. One Phase 3 trial has been completed and no trials are currently active. The completed study was randomized, double blind, and active controlled, enrolling 140 participants with nasal congestion.

What clinical trials is xylo+dex in?

xylo+dex has been studied in one clinical trial, NCT03439436, titled a study to compare two formulations of xylometazoline/dexpanthenol nasal spray for the treatment of nasal congestion. The Phase 3 trial is completed, enrolled 140 adults aged 18 and older, and was conducted in Russia.