A Study of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline (NaCl 09%) for the Relief of Nasal Obstruction

• Status: Unknown status
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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).

The subjects will use the study medication or comparative, according to their randomization, for a treatment period of 3 to 7 days. A follow-up visit will be made 15 days after initiation of treatment.

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

Details

• Lead Sponsor: Zurita Laboratorio Farmaceutico Ltda.
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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