Nasal CongestionPhase 3NCT02601235
Efficacy and Safety of Pediatric Drugs in Nasal Congestion
A Phase 3 study testing Naridrin and Afrin in people with Nasal Congestion, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal congestion. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Nasal Congestion
- What is being tested?
- Naridrin and Afrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Jan 2018to 3 Apr 2019
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants aged 10-17 years old with clinical symptoms of inflammatory of allergic nasal congestion in at least one nostril due to rhinitis or rhinopharyngitis (cold or flu);
- Signed Consent;
- Participants whose mother, father and / or legal guardian is in accordance with all study purposes and procedures;
- Participants with clinical symptoms of nasal congestion in at least one nostril diagnosed through the Glatzel mirror;
- Participants with minimal score of 2 points in the 0 to 3 scale (Moderate obstruction).
Who cannot join
- Participation in clinical trial in the year prior to this study;
- Total obstruction of one of the nostrils by other etiologies that are not inflammatory or allergic;
- Infectious bacterial-disease (clinically diagnosed);
- Participants treated with antibiotic or possible antibiotic use due to another medical condition;
- Use of intranasal corticosteroids (7 days prior to the study) or systemic (15 days prior to the study), regarding the plasma half-life of the drug;
- Use of decongestants or antihistamine (intranasal or systemic) in the 03 days prior to the study;
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- Use of inhaled drugs (except nasal moisturizers such as saline solution) or treatment with immunosuppressants in the week before the study;
- Participants with septum deviation grade II and III, nasal polyps, severe turbinate hypertrophy, adenoid hypertrophy, or other determining factors for nasal obstruction;
- History of hyperthyroidism or hypertension;
- History of hypersensitivity to the components of the study drugs;
- History of transphenoidal hypophysectomy or oronasal surgery with exposure of the dura-mater;
- Exclusive mouth-breathers patients;
- Participants in chronic drug treatment for allergies (eg vaccines for allergy, cromolyn);
- History of alcohol and / or drug abuse 3 months prior to the study;
- Smokers
- Pregnancy or risk of pregnancy and lactating patients;
- PAny clinical, laboratory that, in the judgment of the investigator, may interfere with the safety of research participants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Safety and Efficacy of Pediatric Naridrin in Comparison to Afrin on the Improval of Nasal Congestion.
The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal congestion.
Read the detailed description
Open label, randomized, multicenter clinical study. Maximal experiment duration: 2 days; 2 visits. Safety and efficacy evaluation
- Conditions
- Nasal Congestion
- Being tested
- Naridrin, Afrin
- Keywords
- nasal congestion
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaridrinDrug
Also called Naphazoline Hydrochloride, Mepyramine Maleate, Dexpanthenol
Naridrin® : 2 drops in each nostril once daily as prescription
AfrinDrug
Also called oxymetazoline hydrochloride
2 pumps in each nostril every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Naridrin | Experimental | Naridrin: 2 drops in each nostril once daily as prescription Receives: Drug: Naridrin |
| 0.05 % Oxymetazoline Hydrochloride | Active comparator | 2 pumps in each nostril every 12 hours Receives: Drug: Afrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of Nasal Congestion
Relief of nasal congestion will be measured on a scale of 0 to 3 (0 = without congestion and 3 total congestion)
Measured: 2 days
Secondary outcomes (1)
Adverse Events
Safety of the drug will be assessed by observation of adverse events monitored for the type, frequency and intensity during the days of the follow-up.
The evaluation of the heart frequency will also be a safety parameter.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study start16 Jan 2018
- Primary completion3 Aug 2018
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal CongestionStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601235
- Sponsor's protocol ID
- NMDEMS0214NA-III
- Status last verified
- Oct 2019
- First submitted
- 5 Nov 2015
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Safety and Efficacy of Pediatric Naridrin in Comparison to Afrin on the Improval of Nasal Congestion.
- ClinicalTrials.gov ID
- NCT02601235
- Acronym / sponsor ID
- NMDEMS0214NA-III
- Conditions
- Nasal Congestion
- Keywords
- nasal congestion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 10 Nov 2015 (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.
The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal congestion.
Detailed description
Open label, randomized, multicenter clinical study. Maximal experiment duration: 2 days; 2 visits. Safety and efficacy evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naridrin | Experimental | Drug: NaridrinNaridrin: 2 drops in each nostril once daily as prescription |
| 0.05 % Oxymetazoline Hydrochloride | Active comparator | Drug: Afrin2 pumps in each nostril every 12 hours |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participants aged 10-17 years old with clinical symptoms of inflammatory of allergic nasal congestion in at least one nostril due to rhinitis or rhinopharyngitis (cold or flu);
- Signed Consent;
- Participants whose mother, father and / or legal guardian is in accordance with all study purposes and procedures;
- Participants with clinical symptoms of nasal congestion in at least one nostril diagnosed through the Glatzel mirror;
- Participants with minimal score of 2 points in the 0 to 3 scale (Moderate obstruction).
Key exclusion criteria (17 listed)
- Participation in clinical trial in the year prior to this study;
- Total obstruction of one of the nostrils by other etiologies that are not inflammatory or allergic;
- Infectious bacterial-disease (clinically diagnosed);
- Participants treated with antibiotic or possible antibiotic use due to another medical condition;
- Use of intranasal corticosteroids (7 days prior to the study) or systemic (15 days prior to the study), regarding the plasma half-life of the drug;
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 |
|---|---|---|
| NaridrinAlso: Naphazoline Hydrochloride, Mepyramine Maleate, DexpanthenolNaridrin® : 2 drops in each nostril once daily as prescription | Drug | Naridrin |
| AfrinAlso: oxymetazoline hydrochloride2 pumps in each nostril every 12 hours. | Drug | 0.05 % Oxymetazoline Hydrochloride |
Primary outcome
Relief of Nasal Congestion
Time frame: 2 days
Relief of nasal congestion will be measured on a scale of 0 to 3 (0 = without congestion and 3 total congestion)
1 secondary outcome
Adverse Events
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Naridrin and Afrin in people with Nasal Congestion, run by EMS 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 17 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: finished, as of the sponsor's last update on 16 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of Nasal Congestion (time frame: 2 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 16 Oct 2019.