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

• Status: Completed
• Trial end date: 2018-05-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil AB
• Treatments: Pantothenic Acid; Xylometazoline

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).