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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2010 by Zurita Laboratorio Farmaceutico Ltda..
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Zurita Laboratorio Farmaceutico Ltda.

ClinicalTrials.gov Identifier:

NCT01248325

First received: November 23, 2010

Last updated: NA

Last verified: November 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 23, 2010

Last Updated Date

November 23, 2010

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Improvement of nasal congestion [ Time Frame: 3 days ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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).

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Rhinitis
Sinusitis

Intervention ^ICMJE

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.
Drug: 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.

Study Arm (s)

Experimental: 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.

Intervention: Drug: Luffa Operculate Nasal Solution 5mg/mL
Active Comparator: 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.

Intervention: Drug: Saline Solution (NaCl 0,9%)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Andréa Martinez, doctor's

(11 55) 5082-3634

andrea.martinez@avantipc.com.br

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01248325

Other Study ID Numbers ^ICMJE

ZUR-LO-2009

Has Data Monitoring Committee

Responsible Party

Maria Pilar Michielin Zurita, Zurita Laboratório Farmacêutico Ltda

Study Sponsor ^ICMJE

Zurita Laboratorio Farmaceutico Ltda.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Luis Gregório, doctor's

Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP

Information Provided By

Zurita Laboratorio Farmaceutico Ltda.

Verification Date

November 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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