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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
  Purpose

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.


Condition Intervention Phase
Rhinitis
Sinusitis
 Drug: Luffa Operculate Nasal Solution 5mg/mL
Drug: Saline Solution (NaCl 0,9%)
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Further study details as provided by Zurita Laboratorio Farmaceutico Ltda.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248325

Contacts
Contact: Andréa Martinez, doctor's (11 55) 5082-3634 andrea.martinez@avantipc.com.br

Locations
Brazil
Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP Not yet recruiting
São Paulo, Brazil, 04039-032
Principal Investigator: Luis Gregório, doctor's            
Sponsors and Collaborators
Zurita Laboratorio Farmaceutico Ltda.
Investigators
Principal Investigator: Luis Gregório, doctor's Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
  More Information

No publications provided

Responsible Party: Maria Pilar Michielin Zurita, Zurita Laboratório Farmacêutico Ltda
ClinicalTrials.gov Identifier: NCT01248325     History of Changes
Other Study ID Numbers: ZUR-LO-2009
Study First Received: November 23, 2010
Last Updated: November 23, 2010
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Nasal Obstruction
Rhinitis
Sinusitis
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
 Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Paranasal Sinus Diseases

ClinicalTrials.gov processed this record on June 18, 2013