Efficacy and Safety of Pediatric Drugs in Nasal Congestion
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|ClinicalTrials.gov Identifier: NCT02601235|
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nasal Congestion||Drug: Naridrin Drug: Afrin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||292 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of Safety and Efficacy of Pediatric Naridrin in Comparison to Afrin on the Improval of Nasal Congestion.|
|Actual Study Start Date :||September 28, 2017|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||September 2018|
Naridrin: 2 drops in each nostril once daily as prescription
Naridrin® : 2 drops in each nostril once daily as prescription
Active Comparator: 0.05 % Oxymetazoline Hydrochloride
2 pumps in each nostril every 12 hours
2 pumps in each nostril every 12 hours.
Other Name: oxymetazoline hydrochloride
- 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)
- Adverse Events [ Time Frame: 2 days ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601235
|Contact: Monalisa F.B. Oliveira, M.D.||+ 55 19 email@example.com|
|Faculdade de Medicina do ABC||Recruiting|
|Santo André, SP, Brazil|
|Principal Investigator: Neusa Wandalsen, MD|