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

NCT01055756 | Withdrawn Phase 3

• 2 other identifiers: LOREMS0909Version 3, Amendment 1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical signs and symptoms and nasal flow

  12 hours.

Secondary Outcomes (1)

• Avaliation of Safety through the adverse affects observation

  12 hours

Study Arms (2)

Test (Cloratadd D)

EXPERIMENTAL

Loratadine + Pseudoephedrine sulfate Test

Drug: Loratadine + Pseudoephedrine sulfate

Comparator (Claritin D)

ACTIVE COMPARATOR

Loratadine + Pseudoephedrine Comparator

Drug: Loratadine + Pseudoephedrine sulfate

Interventions

Loratadine + Pseudoephedrine sulfate DRUG

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

Comparator (Claritin D); Test (Cloratadd D)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, 13276245, Brazil

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Loratadine; Acetaminophen

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: January 26, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

BR (1)