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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

This study has been withdrawn prior to enrollment.
Information provided by:
Azidus Brasil Identifier:
First received: December 10, 2009
Last updated: October 26, 2010
Last verified: February 2010
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: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • Clinical signs and symptoms and nasal flow [ Time Frame: 12 hours. ]

Secondary Outcome Measures:
  • Avaliation of Safety through the adverse affects observation [ Time Frame: 12 hours ]

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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01055756

LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13276245
Sponsors and Collaborators
Azidus Brasil
  More Information

Responsible Party: Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda. 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

Keywords provided by Azidus Brasil:
Reduction of signs and symptoms and enhanced nasal flow
Nasal Flow

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating processed this record on August 17, 2017