Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu
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|ClinicalTrials.gov Identifier: NCT02904304|
Recruitment Status : Suspended (the viability of the study is being analyzed)
First Posted : September 16, 2016
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cold||Drug: Desloratadine+Phenylephrine+Ibuprofen Drug: Placebo||Phase 3|
The investigational product is a combination of desloratadine, phenylephrine hydrochloride and ibuprofen.
The desloratadine is a antihistamine and selectively block the activity of histamine receptor-1 (H1) resulting in a non sedative and prolong antiallergic effect.
The phenylephrine is a potent stimulator of the postsynaptic α receptor with minimal effect on β receptors in the heart.
The ibuprofen's mechanism is not fully known. It is a non selective inhibitor of cyclooxygenase, an enzyme that is involved in prostaglandin synthesis by the route from arachidonic acid. It is believed that the pharmacological effects are due to inhibition of cyclooxygenase-2 (COX-2), which reduces prostaglandin synthesis involved in the mediation of inflammation, pain, fever and swelling.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||National Clinical Trial,Phase III, Multicenter, Randomized, Prospective, Double-blind, Parallel, Placebo-controlled, to Evaluate the Efficacy, Safety and Superiority of Decongex Gripe in the Treatment of Symptoms Associated With Common Cold|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||September 2021|
It's a tablet manufactured by Aché S.A., composed of desloratadine 2,5mg, Phenylephrine hydrochloride 20mg and Ibuprofen 400mg.
Tablet will be dispensed in a cartridge containing 10 tablet to 75 participants.
01 tablet, orally, every 12 hours.
Other Name: Desloratadine+Phenylephrine hydrochloride+Ibuprofen
Placebo Comparator: Placebo
It's a tablet manufactured by Aché S.A,. composed of placebo will be dispensed in a cartridge containing 10 tablet to 75 participants. The participants shall administer the placebo tablets to enable the double-blind study.
The use of placebo comparator is important in this type of pathology because with this design will be able to evaluate the response of the pure treatment, rapid relief of symptoms, or 03 hours after the first administration of study drug.
01 tablet, orally, every 12 hours.
- Evaluation of the superiority of Desloratadine + Phenylephrine + Ibuprofen over placebo [ Time Frame: 03 hours after the first dose ]To evaluate the association of the superiority fixed dose of desloratadine 2.5mg, 20mg phenylephrine hydrochloride and ibuprofen 400 mg compared to placebo in the treatment of symptoms related to the common cold / flu syndrome by varying the intensity total score of symptoms, three (03 ) hours after the first dose of investigational product.
- Evaluation of the symptoms related to the common cold / flu syndrome. [ Time Frame: 02 days after initiation of treatment, compared to baseline. ]Absolute variation in total score intensity of symptoms related to the common cold / flu-like symptoms 02 days after the start of treatment compared to baseline.
- Satisfaction of the quality of sleep [ Time Frame: On the first day and on the second day after the start of treatment. ]Distribution of subjects in each treatment group as their perception to the sleep quality, assessed at baseline by answering the following statement: " Last night, with this cold, I did not sleep as well as I usually sleep "based on a scale of 0 to 4 points (0 = strongly disagree, 1 = disagree, 2 = neither agree nor disagree, 3 = agree and 4 = I totally agree).
- The need for use of the rescue medication measured through the subject's diary. [ Time Frame: On the first day and on the second day after the start of treatment. ]Proportion of subject in each treatment group who used at least once the rescue medication (Tylenol®) in the first (Day 01) and on the second day (day 02) after treatment, measured through the subject's diary.
- The need for use of the rescue medication according to accounting of rescue medication returned. [ Time Frame: On the first day and on the second day after the start of treatment. ]Proportion of subject in each treatment group who used at least once the rescue medication (Tylenol®) in the first (Day 01) and on the second day (day 02) after treatment, accounting of rescue medication (Tylenol®) returned.
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): NCT02904304
|Allergisa Pesquisa Dermato Cosmética Ltda.|
|Campinas, São Paulo, Brazil|
|Principal Investigator:||Mauro Crippa Jr.||Allergisa Pesquisa Dermato Cosmética Ltda.|