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.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 25, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedNovember 25, 2010
November 1, 2010
6 months
November 23, 2010
November 23, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Luffa Operculate Nasal Solution 5mg/mL
EXPERIMENTALThe 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%)
ACTIVE COMPARATORThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
São Paulo, São Paulo, 04039-032, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Gregório, doctor's
Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 25, 2010
Study Start
January 1, 2011
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
November 25, 2010
Record last verified: 2010-11