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A Study to Compare Two Formulations of Xylometazoline/Dexpanthenol Nasal Spray for the Treatment of Nasal Congestion.
A Study to Compare Two Formulations of Xylometazoline/Dexpanthenol Nasal Spray for the Treatment of Nasal Congestion.

NCT03439436

CompletedPhase 3

Sponsor: McNeil AB

Conditions: Nasal Congestion

Interventions: xylo+dex nasal spray (0.1 mg+5 mg/dose), Nasic

Countries: Russia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 to 35 (inclusive) at screening;
* Indicate at least moderate congestion on a categorical scale ranging from (0) none, (1) mild, (2) moderate, (3) severe or (4) very severe, completed at screening and at baseline;
* Females of childbearing potential must have a negative urine pregnancy test at screening;
* Male and non-pregnant, non-lactating females must agree to the contraceptive requirements (including female partners' use of highly effective form of birth control for at least 3 months before the study, during the study and up to 30 days after the last dose of investigational products) as outlined in protocol.
* Are able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel´s assessment;
* Are able to read and understand the local language;
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.

Exclusion Criteria

* Females who are pregnant, breastfeeding or trying to conceive;
* Male with a pregnant partner or a partner who is currently trying to conceive;
* Have a known allergy or hypersensitivity to xylometazoline, dexpanthenol or any of the excipients of the formulations;
* Presence or history of a medical condition in the investigator's opinion that may jeopardize the subject´s safety or well-being, or the integrity of the study (e.g., hepatic, renal, pancreatic, gastrointestinal, cardiovascular, cerebrovascular, thyroid, seizure, asthma, allergy, drug intolerance, or psychiatric disorders; uncontrolled hypertension indicated as systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg; or uncontrolled diabetes in the last 6 months);
* Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
* Clinically significant laboratory abnormality that cannot be explained by the acute upper respiratory tract infection;
* Presenting axillary temperature of 38.5 Celsius degrees or above;
* Acute and/or chronic respiratory tract disease or other concomitant disease with potential to compromise breathing (asthma, bronchopneumonia);
* Chronic ear, nose and throat (ENT) conditions e.g. nasal polyps, perennial or seasonal allergic rhinitis, or significant nasal septum deviation;
* Suspected fungal upper respiratory tract infection e.g., candida infection;
* Known or suspected bacterial upper respiratory tract infection or purulent pharyngitis;
* Have contraindicated conditions: arterial hypertension, tachycardia, marked atherosclerosis, atrophic rhinitis, rhinitis sicca, hyperthyroidism, porphyria, prostatic hyperplasia, glaucoma, previous surgical intervention on the meninges;
* Are currently taking monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants;
* Use of any analgesic, antipyretic or "cold and flu" medication including non-prescription medication and/or herbal products within previous 8 hours, for naproxen containing products within previous 12 hours;
* Use of any nasal or oral decongestant including non-prescription medication and/or herbal products for the presenting episode of nasal congestion;
* Use of any menthol containing medications or confectionary including non-prescription medication and/or herbal products within 6 hours of baseline;
* Participation in any interventional clinical trials within 30 days before screening or had previous participation in this trial;
* Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., Principal Investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson subsidiaries, contractors of Johnson \& Johnson, and the families of each).
Locations (5)
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Saint Petersburg, Russia
  • Saint Petersburg, Russia