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

Sinusitis Clinical Trial

Official title:

Clinical Trial Unicenter, Phase III, Randomized, Double-blind, Comparative to Evaluate the Efficacy, Tolerability and Superiority of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline Solution in the Relief of Nasal Obstruction.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01248325
• Other study ID #: ZUR-LO-2009
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 23, 2010
• Last updated: November 23, 2010
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: November 2010
• Source: Zurita Laboratorio Farmaceutico Ltda.
• Contact: Andréa Martinez, doctor's
• Phone: (11 55) 5082-3634
• Email: andrea.martinez[@]avantipc.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Obstruction
• Rhinitis
• Sinusitis

Intervention

Drug:
• Luffa Operculate Nasal Solution 5mg/mL
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
• Saline Solution (NaCl 0,9%)
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Zurita Laboratorio Farmaceutico Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of nasal congestion	If the patient present a improvement of nasal congestion 3 days after the treatment start, the treatment will be discontinued and the patient will perfomr the Visit 2.	3 days	No