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Comparative Effectiveness of Two Associations of Loratadine + Pseudoephedrine, Cloratadd-d ® (Coated Pill) Produced by the Laboratory Ems and Claritin-d ® (dräger), Produced by Schering-plough in Patients With Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01228630
First received: October 18, 2010
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

The hypothesis to be investigated in this study is that drug testing is as effective as the comparator drug, with regard to relief of symptoms of perennial allergic rhinitis.


Condition Intervention Phase
Perennial Allergic Rhinitis
 Drug: Loratadine + pseudoephedrine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of Two Commercial Preparations of Loratadine + Pseudoephedrine Cloratadd-d ® (Coated Pill) Produced by the Laboratory EMS S / AE Claritin-d ® (dräger), Produced by Schering-plough SA, in Patients With Perennial Allergic Rhinitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Signs and symptoms evaluated by a PHYSICIAN [ Time Frame: 28 days of treatment. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Symptoms reported by PATIENTS [ Time Frame: 28 days of treatment. ] [ Designated as safety issue: No ]
    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.


Enrollment: 156
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 - Test
  • Loratadine 05 mg + 120 mg of sulfate pseudoefredina (dragee)
  • Coated tablet PLACEBO (identical to comparator)

Because of this clinical trial involving major differences between the appearance of dosage units of drugs in comparison, the masking will be performed by double-quote (Double-Dummy).

Thus, the Laboratory EMS will adopt the following:

  1. Preparation of a placebo medication with the same characteristics of the drug Claritin D ®;
  2. Preparation of a placebo medication with the same product characteristics Cloratadd D ®;
  3. Allocation of medicine (active + placebo) treatment in individual cases; At the final visit, patients will be instructed to bring the center to study medication, which will be retained for counting.

With this masking procedure, the principal investigator and the patient will not be aware of the drug dispensed, ensuring the proper conduct to meet the goals established in this protocol.

 Drug: Loratadine + pseudoephedrine
2 times per day for 28 days
Active Comparator: Comparator
  • Loratadine 05 mg + 120 mg of sulfate pseudoefredina (coated tablet)
  • Dragee PLACEBO (identical to Test)

Because of this clinical trial involving major differences between the appearance of dosage units of drugs in comparison, the masking will be performed by double-quote (Double-Dummy).

Thus, the Laboratory EMS will adopt the following:

  1. Preparation of a placebo medication with the same characteristics of the drug Claritin D ®;
  2. Preparation of a placebo medication with the same product characteristics Cloratadd D ®;
  3. Allocation of medicine (active + placebo) treatment in individual cases; At the final visit, patients will be instructed to bring the center to study medication, which will be retained for counting.

With this masking procedure, the principal investigator and the patient will not be aware of the drug dispensed, ensuring the proper conduct to meet the goals established in this protocol.

 Drug: Loratadine + pseudoephedrine
2 times per day for 28 days

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Comply with all the purposes and procedures of the study by signing and dating the IC own free will. In the case of minors, the document should be signed and dated by the parent or legal guardian;
  • Have age over 12 years, regardless of gender, ethnicity or social class;
  • Present clinical status of perennial allergic rhinitis from mild to moderate;
  • Present clinical status with at least 12 months of evolution;
  • Submit the examination of IgE elevation (above 100KU / L).

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:

    1. Intranasal or systemic corticosteroids in the month before inclusion;
    2. Intranasal cromolyn in the two weeks preceding inclusion;
    3. Intranasal or systemic decongestants in the 03 days preceding inclusion;
    4. Intranasal antihistamines or systemic in the 03 days preceding the survey;
    5. Loratadine in the 10 days preceding the survey.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228630

Locations
Brazil
Lal Clínica Pesquisa E Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil, 13270-245
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Dr. Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01228630     History of Changes
Other Study ID Numbers: LOREMS0810
Study First Received: October 18, 2010
Last Updated: February 22, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pseudoephedrine
Ephedrine
Loratadine
Nasal Decongestants
Vasoconstrictor Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Central Nervous System Stimulants
Central Nervous System Agents
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013