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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.
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