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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00724698
First received: July 25, 2008
Last updated: May 28, 2009
Last verified: May 2009
  Purpose

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 Intervention
Rhinitis
Urticaria
Drug: Desloratadine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Tablet Among Filipino Patients

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Final Visit (Day 15) ] [ Designated as safety issue: Yes ]

Enrollment: 3011
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group
Patients diagnosed with Allergic Rhinitis or Chronic Idiopathic Urticaria
Drug: Desloratadine
Desloratadine 5 mg once daily
Other Name: SCH 034117

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00724698     History of Changes
Other Study ID Numbers: P04706
Study First Received: July 25, 2008
Results First Received: May 28, 2009
Last Updated: May 28, 2009
Health Authority: Philippines: Bureau of Food and Drugs

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

ClinicalTrials.gov processed this record on November 23, 2014