Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| EMS S/A | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The loratadine-pseudoephedrine combination has proven to be more effective than the use of these individual components. This prospective, randomized, double-blind and paralel study, in which patients with perennial allergic rhinitis receive one of loratadine + pseudoephedrine association drug for treatment of signs and symptoms during 4 weeks.
The effectiveness of treatment in each drug group will be evaluate by global improvement of signs (nasal mucous edema, ocular hyperemia, nasal secretion) and symptoms (itching eye, tearing,itching nose, itching on the palate) of perennial allergic rhinitis, after 4 weeks of treatment. Symptoms as rhinorrhea, nasal congestion, itching nose, sneezing and itching eye were considered as secondary efficacy endpoint, along with the questionnaire of quality of life SF-36. Safety evaluation data will include report of all adverse events (including type, frequency, instensity, seriousness, severity and action taken related to investigational product) reported by patients, parents or legal responsible, ou observed by Investigator.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cloratadd-D | Experimental | Loratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to comparator drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water. |
|
| Allegra-D | Active Comparator | Loratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to test drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cloratadd-D | Drug | The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Signs and symptoms evaluated by a PHYSICIAN | Signs of swelling of nasal mucosa,ocular hyperemia and nasal discharge. Symptoms of itchy eyes, watery eyes,itchy nose and itching of the palate. These signs and symptoms will be assessed during 04 scheduled visits: -7 days, 0 day, 7 days and 28 days. | 28 days of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms reported by PATIENTS | Symptoms of runny nose,nasal congestion, itchy nose, sneezing, quality of life.These signs and symptoms will be assessed during 04 scheduled visits: -7 days, 0 day, 7 days and 28 days. | 28 days of treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Have participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
Pregnant or lactating women;
Have made use of:
have any disease or anatomical abnormality in the upper airways which could jeopardize the analysis of data, for example, tumors or severe septal deviations;
History of smoking in the 03 months preceding the inclusion;
History of alcohol or illicit drugs;
History of liver disease or kidney disease;
Electric current asthma or gift last year;
Table of uncontrolled hypertension;
Patients with heart disease or who use drugs for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers;
Patients with flu-like symptoms or fever of unknown origin, defined current or within last 07 days;
Clinical diagnosis of rhinitis is not that kind of allergic and perennial;
Be patient with sensitivity to loratadine, pseudoephedrine sulfate, or any components of the formula;
Estimated travel or displacement of the southeast for more than 50% of monitoring.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luiz Tikara Shimizu, PI | LAL Clinica Pesquisa e Desenvolvimento Ltda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lal ClÃnica Pesquisa E Desenvolvimento Ltda | Valinhos | São Paulo | 13270-245 | Brazil |
It believed that after the data analysis and presentation to the IRC, all data will become public.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| D017336 | Loratadine |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Allegra-D | Drug | The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water. |
|
|
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |