A Phase 3 interventional study of xylo+dex nasal spray (0.1 mg+5 mg/dose) and Nasic in Nasal Congestion, sponsored by McNeil AB. Completed at 5 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-18.
Sponsored by McNeil AB (formerly part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
An observer-blind, multi-centre, randomized, parallel-group study to compare the efficacy and safety of two formulations of xylometazoline/dexpanthenol nasal spray for the treatment of nasal congestion caused by an acute upper respiratory tract infection in adults.
This observer-blind multi-center, randomized, parallel-group study in adults is designed to demonstrate non-inferiority between two formulations of xylometazoline/dexpanthenol nasal sprays in terms of efficacy and safety, when the products are used according to labeled instructions in a home based setting.
Subjects suffering from nasal congestion caused by acute Upper Respiratory Tract Infection (URTI) and seeking medical counselling, will after screening and baseline assessment of nasal congestion, be randomized, and perform additional baseline subjective assessments of nasal rhinorrhea (scores on categorical scales). The Investigator will perform subjective baseline assessments of crust formation and dryness, redness and edema of nasal mucosa (anterior rhinoscopy using nasal speculum or otoscope).
After the baseline assessments, the subjects will receive xylometazoline/dexpanthenol nasal spray or marketed reference nasal spray according to randomization.The first dose will be taken at the site under supervision. The study nurse will schedule visits for 24 hours, 72 hours and 120 hours after this first dose and the subjects will be released for home based treatment. At the 72-hour visit, the primary and secondary efficacy endpoints will be assessed by the subject and the Investigator, safety will be followed up and subjects will also evaluate the treatment in a global assessment. At the 24-hour visit and at the final visit, after a maximum of 5 full days (120 hours) of treatment, all secondary endpoints will be assessed and safety will be followed up.
173 studies on the registry are indexed under Nasal Obstruction; 31 are open to participants now.
This study's enrollment of 140 is above the median of 70 across 139 interventional studies indexed under Nasal Obstruction.
Browse Nasal Obstruction studies →McNeil AB is the lead sponsor of 42 studies on the registry; 1 is open to participants now.
First submitted before McNeil AB left Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Xylometazoline+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.
Drug: xylo+dex nasal spray (0.1 mg+5 mg/dose)
Xylometazoline+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.
Drug: Nasic
Drug page: Dextromethorphan
Xylometazoline+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.
Also known as: xylo+dex metered nasal spray (0.1 mg+5 mg/dose)
Xylometazoline+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.
Also known as: xylo+dex metered nasal spray (0.1 mg+5 mg/dose)
Change from baseline in self-assessment of nasal congestion after 72 hours of treatment.
Change from baseline in self-assessment of nasal congestion after 72 hours of treatment.
Time frame: After 72 hours of treatment.
Change from baseline in self-assessment of nasal congestion at 24 and 120 hours post dose.
Change from baseline in self-assessment of nasal congestion at 24 and 120 hours post dose.
Time frame: At 24 and 120 hours post dose.
Change from baseline in self-assessment of rhinorrhea after 24 hours, 72 and 120 hours post dose.
Change from baseline in self-assessment of rhinorrhea after 24 hours, 72 and 120 hours post dose.
Time frame: At 24 hours, 72 and 120 hours post dose
Assessment of nasal crusting after 24 hours, 72 hours and 120 hours post dose.
Assessment of nasal crusting after 24 hours, 72 hours and 120 hours post dose.
Time frame: At 24 hours, 72 hours and 120 hours post dose.
Assessment of dryness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Assessment of dryness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Time frame: At 24 hours, 72 hours and 120 hours post dose.
Assessment of redness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Assessment of redness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Time frame: At 24 hours, 72 hours and 120 hours post dose.
Assessment of edema of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Assessment of edema of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Time frame: At 24 hours, 72 hours and 120 hours post dose
Global evaluation assessments of study treatment by subjects at 72 hours post dose.
Global evaluation assessments of study treatment by subjects at 72 hours post dose.
Time frame: At 72 hours post dose.
Frequency and severity of treatment emergent AEs reported during the study.
Each treatment emergent AE reported during the trial and it´s severity will be tabulated in a list, capturing frequency and severity of all treatment emergent AEs occuring during the trial.
Time frame: Through study completion, an average of 5 months.
Frequency and severity of AEs possibly, probably, or very likely related to the study drug during study treatment.
Each AE which has been ranked as possibly, probably, or very likely related to the study drug during study treatment will be tabulated in a list capturing frequency and severity of all these AEs occuring during the trial.
Time frame: Through study completion, an average of 5 months.
Occurrence of serious AEs (SAEs).
Occurrence of serious AEs (SAEs), will be tabulated in a list.
Time frame: Through study completion, an average of 5 months.
Occurence of AEs resulting in pre-mature withdrawal from the study.
Occurence of AEs resulting in pre-mature withdrawal from the study will be tabulated in a list.
Time frame: Througout study completion, an average of 5 months.
Subject compliance with the study medication dosing regimen by reporting of doses taken in subject diary.
Subject compliance with the study medication dosing regimen by reporting of doses taken in subject diary.
Time frame: Through study completion, an average of 5 months.
Plan to share: No
Ran from Feb 2018 to primary completion in May 2018, 2 months.
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dextromethorphan