Clinical trial NCT02904304: Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Cold
Keywords: Flu
Treatment
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: National clinical trial, phase III, multicenter, randomized, prospective, double-blind, parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged equal or more than 18 years will be randomly allocated to one the drug group or placebo group.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age older or equal to 18 and younger than 66 years;
* Subjects diagnosed with common cold / flu syndrome defined by clinical evaluation and the presence of two or more of the following symptoms: sneezing, rhinorrhea, nasal obstruction, headache, throat discomfort, sore throat, dysphonia, myalgia, cough and fever classified as moderate or intense in four intensity scale (04) items (0 = absent, 01 = light, 02 = moderate, 03 = severe);
* Beginning of the symptoms of common cold / flu-like syndrome in a minimum period of 24 hours and a maximum of 72 hours prior to V0;
* Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF);

Exclusion Criteria:

* Any laboratorial finding (clinical evaluation / physical evaluation / vital signs / ECG changes) that the Investigator consider a risk to subject of the study;
* Hypersensitivity to the drug components used during the study;
* Women in pregnancy or nursing period;
* Women in reproductive age who do not agree to use contraception acceptable \[oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation\]; other than surgically sterile (bilateral oophorectomy or hysterectomy), postmenopausal for at least one (01) years or sexual abstinence;
* Subjects that has participated in clinical trial protocols in the last twelve (12) months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;
* Alcohol abuse that, according to the investigator, may interfere with the pharmacological adherence to the clinical protocol;
* Any medical conditions which may interfere with efficacy and / or safety of the treatment with the investigational product, such as but not limited to disorders described below:
* Untreated or uncontrolled Hyperthyroidism
* Uncontrolled epilepsy
* diagnosis of glaucoma
* Moderate or severe persistent asthma (untreated or uncontrolled)
* NSAID-induced asthma diagnosed
* Systemic hypertension (SH) stage III uncontrolled
* Moderate and severe congestive heart failure
* Acute myocardial infarction
* unstable angina
* Uncontrolled cardiac arrhythmia
* Liver failure with clinical consequences
* Renal failure with clinical consequences
* Diagnosed HIV positive
* uncontrolled Diabetes type 1 or type 2

Primary outcomes:
measure: Evaluation of the superiority of Desloratadine + Phenylephrine + Ibuprofen over placebo
timeFrame: 03 hours after the first dose
Secondary outcomes:
measure: Evaluation of the symptoms related to the common cold / flu syndrome.
timeFrame: 02 days after initiation of treatment, compared to baseline.
measure: Satisfaction of the quality of sleep
timeFrame: On the first day and on the second day after the start of treatment.
measure: The need for use of the rescue medication measured through the subject's diary.
timeFrame: On the first day and on the second day after the start of treatment.
measure: The need for use of the rescue medication according to accounting of rescue medication returned.
timeFrame: On the first day and on the second day after the start of treatment.
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa Pesquisa Dermato Cosmética Ltda.
state: São Paulo
Study officials:
affiliation: Allergisa Pesquisa Dermato-Cosmética Ltda
name: Mauro Crippa Jr.
role: PRINCIPAL_INVESTIGATOR
References: