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Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria (Aerius)

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ClinicalTrials.gov Identifier: NCT00724698
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : July 17, 2009
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability and clinical efficacy will be measured.

Condition or disease Intervention/treatment
Rhinitis Urticaria Drug: Desloratadine

Study Type : Observational
Actual Enrollment : 3011 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Tablet Among Filipino Patients
Study Start Date : October 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
U.S. FDA Resources

Group/Cohort Intervention/treatment
Group
Patients diagnosed with Allergic Rhinitis or Chronic Idiopathic Urticaria
Drug: Desloratadine
Desloratadine 5 mg once daily
Other Name: SCH 034117



Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Final Visit (Day 15) ]
    Number of adverse events reported



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Filipino patients diagnosed to have Allergic Rhinitis or Chronic Idiopathic Urticaria
Criteria

Inclusion Criteria:

  • Outpatient men or women, age 12 years and above.
  • Diagnosis of Allergic Rhinitis or Chronic Idiopathic Urticaria

Exclusion Criteria:

  • Known hypersensitivity to Desloratadine.
  • Pregnancy or lactation

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724698     History of Changes
Other Study ID Numbers: P04706
First Posted: July 29, 2008    Key Record Dates
Results First Posted: July 17, 2009
Last Update Posted: February 23, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Rhinitis
Urticaria
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desloratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents