RhinitisPhase 3NCT01248325
A Study of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline (NaCl 09%) for the Relief of Nasal Obstruction
A Phase 3 study testing Luffa Operculate Nasal Solution 5mg/mL and Saline Solution (NaCl 0,9%) in people with Rhinitis and Sinusitis, run by Zurita Laboratorio Farmaceutico Ltda. at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- Luffa Operculate Nasal Solution 5mg/mL and Saline Solution (NaCl 0,9%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
São Paulo, São Paulo, 04039-032
Luis Gregório, doctor's
About this study
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.
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.
- Being tested
- Luffa Operculate Nasal Solution 5mg/mL, Saline Solution (NaCl 0,9%)
- Medical subject headings
- Rhinitis, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luffa Operculate Nasal Solution 5mg/mLDrug
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.
Saline Solution (NaCl 0,9%)Drug
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 group | Role | What they receive |
|---|---|---|
| Luffa Operculate Nasal Solution 5mg/mL | Experimental | 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. Receives: Drug: Luffa Operculate Nasal Solution 5mg/mL |
| Saline Solution (NaCl 0,9%) | Active comparator | 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. Receives: Drug: Saline Solution (NaCl 0,9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zurita Laboratorio Farmaceutico Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luis Gregório, doctor's, Principal investigator, Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248325
- Sponsor's protocol ID
- ZUR-LO-2009
- Status last verified
- Nov 2010
- First submitted
- 23 Nov 2010
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01248325
- Acronym / sponsor ID
- ZUR-LO-2009
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zurita Laboratorio Farmaceutico Ltda.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luffa Operculate Nasal Solution 5mg/mL | Experimental | Drug: Luffa Operculate Nasal Solution 5mg/mLThe 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 comparator | 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Luffa Operculate Nasal Solution 5mg/mLThe 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 |
| 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%) |
Primary outcome
Improvement of nasal congestion
Time frame: 3 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Gregório, doctor's principal investigator
Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Luffa Operculate Nasal Solution 5mg/mL and Saline Solution (NaCl 0,9%) in people with Rhinitis and Sinusitis, run by Zurita Laboratorio Farmaceutico Ltda. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andréa Martinez, doctor's ((11 55) 5082-3634, andrea.martinez@avantipc.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of nasal congestion (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2010.