Recent Updates
Recently added Catalysts

xylo+dex

Phase 3

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

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.
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about xylo+dex

What is xylo+dex used for?

xylo+dex is an investigational small molecule nasal spray being developed for the treatment of nasal congestion. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug combines xylometazoline and dexpanthenol in a single formulation.

What does xylo+dex target?

xylo+dex contains xylometazoline, a decongestant that works by constricting blood vessels in the nasal passages, and dexpanthenol, which is believed to support mucosal healing. The combination is designed to relieve nasal congestion while potentially aiding tissue recovery.

Who makes xylo+dex?

xylo+dex is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 3 clinical development for nasal congestion.

What phase is xylo+dex in?

xylo+dex is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of nasal congestion in adult patients.

What clinical trials is xylo+dex in?

xylo+dex has one completed Phase 3 clinical trial, NCT03439436, which compared two formulations of xylometazoline/dexpanthenol nasal spray for treating nasal congestion. The randomized, double-blind, active-controlled study enrolled 140 participants in Russia and has been completed.