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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01055756
First received: December 10, 2009
Last updated: October 26, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Drug: Loratadine + Pseudoephedrine sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Clinical signs and symptoms and nasal flow [ Time Frame: 12 hours. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Avaliation of Safety through the adverse affects observation [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2010
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test (Cloratadd D)
Loratadine + Pseudoephedrine sulfate Test
Drug: Loratadine + Pseudoephedrine sulfate
Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)
Active Comparator: Comparator (Claritin D)
Loratadine + Pseudoephedrine Comparator
Drug: Loratadine + Pseudoephedrine sulfate
Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Accept the Consent Form.
  2. Age between 18 and 60 years, regardless of sex;
  3. Agree to return to all evaluations of the study;
  4. 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:

  1. Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
  2. 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;
  3. Be patient with sensitivity loratadine / pseudoephedrine sulfate;
  4. 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
  5. Demonstrate a history of alcohol abuse, drugs or pharmaceuticals.
  6. Have consumed alcohol within 48 hours prior to the period of hospitalization;
  7. Have a history of liver disease or kidney disease;
  8. Present framework of current asthma or recent (less than 1 year);
  9. To present the severe pressure of any cause or be on medication for that;
  10. Smokers or patients who stopped smoking less than 06 months;
  11. Pregnant or nursing women;
  12. Patients with heart disease or who use medication for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers;
  13. Patients using corticosteroids or other medicines that interact with the study drugs as monoamine oxidase;
  14. Patients with a history of glaucoma, urinary retention, and hyperthyroidism;
  15. Patients who have undergone facial plastic surgery that the physician's discretion, will interfere with nasal airflow
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055756

Locations
Brazil
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13276245
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01055756     History of Changes
Other Study ID Numbers: LOREMS0909, Version 3, Amendment 1
Study First Received: December 10, 2009
Last Updated: October 26, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Reduction of signs and symptoms and enhanced nasal flow
Nasal Flow

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
Ephedrine
Pseudoephedrine
Loratadine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants

ClinicalTrials.gov processed this record on October 19, 2014