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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

November 23, 2010
November 23, 2010
January 2011
July 2011   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline (NaCl 09%) for the Relief of Nasal Obstruction
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Rhinitis
  • Sinusitis
  • 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.
  • 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%)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Andréa Martinez, doctor's (11 55) 5082-3634 andrea.martinez@avantipc.com.br
Brazil
 
NCT01248325
ZUR-LO-2009
No
Maria Pilar Michielin Zurita, Zurita Laboratório Farmacêutico Ltda
Zurita Laboratorio Farmaceutico Ltda.
Not Provided
Principal Investigator: Luis Gregório, doctor's Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
Zurita Laboratorio Farmaceutico Ltda.
November 2010

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