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Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status

Withdrawn

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Loratadine + Pseudoephedrine sulfate

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Reduction of signs and symptoms and enhanced nasal flow, Nasal Flow

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Accept the Consent Form.
Age between 18 and 60 years, regardless of sex;
Agree to return to all evaluations of the study;
Presenting the allergic symptoms confirmed by physical examination and by laboratory tests (IgE and sensitivity to the mite Dermatophagoides pteronyssinus), which should provide a diagnosis of allergic rhinitis with mild to moderate.

Exclusion Criteria:

Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
Made use of other medications that interfere with the regular response of the drug in the 4 weeks preceding the start of the study, such as steroids and antihistamines;
Be patient with sensitivity loratadine / pseudoephedrine sulfate;
Have any disease or anatomical abnormality in the upper airways is detrimental to the analysis of data, for example, tumors or septal deviations moderate and severe
Demonstrate a history of alcohol abuse, drugs or pharmaceuticals.
Have consumed alcohol within 48 hours prior to the period of hospitalization;
Have a history of liver disease or kidney disease;
Present framework of current asthma or recent (less than 1 year);
To present the severe pressure of any cause or be on medication for that;
Smokers or patients who stopped smoking less than 06 months;
Pregnant or nursing women;
Patients with heart disease or who use medication for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers;
Patients using corticosteroids or other medicines that interact with the study drugs as monoamine oxidase;
Patients with a history of glaucoma, urinary retention, and hyperthyroidism;
Patients who have undergone facial plastic surgery that the physician's discretion, will interfere with nasal airflow

Sites / Locations

LAL Clínica Pesquisa e Desenvolvimento Ltda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test (Cloratadd D)

Comparator (Claritin D)

Arm Description

Loratadine + Pseudoephedrine sulfate Test

Loratadine + Pseudoephedrine Comparator

Outcomes

Primary Outcome Measures

Clinical signs and symptoms and nasal flow

Secondary Outcome Measures

Avaliation of Safety through the adverse affects observation

Full Information

NCT ID

NCT01055756

First Posted

December 10, 2009

Last Updated

October 27, 2022

Sponsor

Azidus Brasil

1. Study Identification

Unique Protocol Identification Number

NCT01055756

Brief Title

Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Withdrawn

Study Start Date

January 2010 (undefined)

Primary Completion Date

April 2010 (Anticipated)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Azidus Brasil

4. Oversight

5. Study Description

Brief Summary

The primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and laboratory (nasal flow) down through time.

Detailed Description

Secondly, it will be observed safety (tolerability) clinic after the administration of the drug in patients by comparing the clinical parameters and the incidence of adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Reduction of signs and symptoms and enhanced nasal flow, Nasal Flow

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test (Cloratadd D)

Arm Type

Experimental

Arm Description

Loratadine + Pseudoephedrine sulfate Test

Arm Title

Comparator (Claritin D)

Arm Type

Active Comparator

Arm Description

Loratadine + Pseudoephedrine Comparator

Intervention Type

Drug

Intervention Name(s)

Loratadine + Pseudoephedrine sulfate

Intervention Description

Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)

Primary Outcome Measure Information:

Title

Clinical signs and symptoms and nasal flow

Time Frame

12 hours.

Secondary Outcome Measure Information:

Title

Avaliation of Safety through the adverse affects observation

Time Frame

12 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Accept the Consent Form. Age between 18 and 60 years, regardless of sex; Agree to return to all evaluations of the study; Presenting the allergic symptoms confirmed by physical examination and by laboratory tests (IgE and sensitivity to the mite Dermatophagoides pteronyssinus), which should provide a diagnosis of allergic rhinitis with mild to moderate. Exclusion Criteria: Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study; Made use of other medications that interfere with the regular response of the drug in the 4 weeks preceding the start of the study, such as steroids and antihistamines; Be patient with sensitivity loratadine / pseudoephedrine sulfate; Have any disease or anatomical abnormality in the upper airways is detrimental to the analysis of data, for example, tumors or septal deviations moderate and severe Demonstrate a history of alcohol abuse, drugs or pharmaceuticals. Have consumed alcohol within 48 hours prior to the period of hospitalization; Have a history of liver disease or kidney disease; Present framework of current asthma or recent (less than 1 year); To present the severe pressure of any cause or be on medication for that; Smokers or patients who stopped smoking less than 06 months; Pregnant or nursing women; Patients with heart disease or who use medication for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers; Patients using corticosteroids or other medicines that interact with the study drugs as monoamine oxidase; Patients with a history of glaucoma, urinary retention, and hyperthyroidism; Patients who have undergone facial plastic surgery that the physician's discretion, will interfere with nasal airflow

Facility Information:

Facility Name

LAL Clínica Pesquisa e Desenvolvimento Ltda

City

Valinhos

State/Province

São Paulo

ZIP/Postal Code

13276245

Country

Brazil

12. IPD Sharing Statement

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