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

Primary Purpose

Rhinitis, Sinusitis

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Luffa Operculate Nasal Solution 5mg/mL
Saline Solution (NaCl 0,9%)
Sponsored by
Zurita Laboratorio Farmaceutico Ltda.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Luffa Operculate Nasal Solution 5mg/mL

Saline Solution (NaCl 0,9%)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2010
Last Updated
November 23, 2010
Sponsor
Zurita Laboratorio Farmaceutico Ltda.
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1. Study Identification

Unique Protocol Identification Number
NCT01248325
Brief Title
A Study of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline (NaCl 09%) for the Relief of Nasal Obstruction
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zurita Laboratorio Farmaceutico Ltda.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Luffa Operculate Nasal Solution 5mg/mL
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline Solution (NaCl 0,9%)
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Luffa Operculate Nasal Solution 5mg/mL
Intervention Description
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 Type
Drug
Intervention Name(s)
Saline Solution (NaCl 0,9%)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of nasal congestion
Description
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.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andréa Martinez, doctor's
Phone
(11 55) 5082-3634
Email
andrea.martinez@avantipc.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Gregório, doctor's
Organizational Affiliation
Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
City
São Paulo
ZIP/Postal Code
04039-032
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Gregório, doctor's

12. IPD Sharing Statement

Learn more about this trial

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

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