Status:
COMPLETED
A Study to Compare Two Formulations of Xylometazoline/Dexpanthenol Nasal Spray for the Treatment of Nasal Congestion.
Lead Sponsor:
McNeil AB
Conditions:
Nasal Congestion
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 congestio...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2018
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03439436
Start Date
February 26 2018
End Date
May 2 2018
Last Update
October 18 2018
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Railways clinical hospital n.a.Semashko at Lublino station JSC "RZD"
Moscow, Russia, 109386
2
City Polyclinic #2
Moscow, Russia, 117556
3
First Moscow State Medical University n. a. I. M. Sechenov
Moscow, Russia, 119991
4
"Scientific and Research centre Eco-safety" Limited Liability Company
Saint Petersburg, Russia, 196143