Status:
UNKNOWN
A Study of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline (NaCl 09%) for the Relief of Nasal Obstruction
Lead Sponsor:
Zurita Laboratorio Farmaceutico Ltda.
Conditions:
Rhinitis
Sinusitis
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Sixty subjects will take part in this study. The subjects will be randomly assigned in a 1:1 ratio between the two arms of study. (Group A: Solution of Luffa Nasal Operculate 5mg/mL, Group B: saline)....
Eligibility Criteria
Inclusion
- Subjects of both sexes aged over 18 years.
- Presence of nasal congestion due to colds, rhinitis, influenza, sinusitis and acute or chronic sinusitis
- Sign the Informed Consent Form
- Comply the study requirements and attend to study visits
- Female subjects must have a NEGATIVE urine pregnancy test during the screening.
Exclusion
- Known allergy to any study product component
- Subject pregnant, lactating or of childbearing potential and not using adequate and effective contraceptive
- Vasoconstrictor nasal topic or oral
- Use of a decongestant nasal whatever the route of administration
- Use of intranasal corticosteroids
- Use of antiallergic
- Use of medication containing atropine
- Subjects that are participating in another study or who participated in another study, less than 12 months
- Any subjects deemed unsuitable for study by the Principal Investigator
- Abuse of alcohol or illicit drugs
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01248325
Start Date
January 1 2011
End Date
July 1 2011
Last Update
November 25 2010
Active Locations (1)
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1
Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
São Paulo, São Paulo, Brazil, 04039-032