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Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01509209
First Posted: January 12, 2012
Last Update Posted: May 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
  Purpose
The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis

Condition Intervention Phase
Vasomotor Rhinitis Drug: Pseudoephedrine / Levocetirizine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • TVRSS(Total Vasomotor Rhinitis Symptom Score) [ Time Frame: 2week ]
    the change from baseline in TVRSS


Secondary Outcome Measures:
  • TVRSS, VRSS [ Time Frame: 1week or 2 week ]
    • the change from baseline in TVRSS during 1st week and 2nd week
    • the change from baseline in each vasomotor rhinitis symptom score at overall, during 1st week/2week


Enrollment: 137
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo
Drug: Pseudoephedrine / Levocetirizine
tablet, BID everyday
Other Name: Cossac L
Experimental: Cossac L
Pseudoephedrine 120mg + Levocetirizine 2.5mg
Drug: Pseudoephedrine / Levocetirizine
tablet, BID everyday
Other Name: Cossac L

Detailed Description:
randomized, double-blind, placebo-controlled, phase 3
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of vasomotor rhinitis

Exclusion Criteria:

  • Significant concomitant medical condition
  • Use corticosteroids or other allergy medications during the study
  • Considered by investigator as not appropriate to participate in the clinical study with othe reason
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509209


Locations
Korea, Republic of
ear, nose and throat, Boramae Hospital
Dongjak, Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Study Director: Kyungmi Park, Ph.D. Hanmi Pharmaceutical Company Limited
  More Information

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01509209     History of Changes
Other Study ID Numbers: HM-LCT-301
First Submitted: January 10, 2012
First Posted: January 12, 2012
Last Update Posted: May 23, 2013
Last Verified: May 2013

Keywords provided by Hanmi Pharmaceutical Company Limited:
vasomotor
pseudoephedrine
levocetirizine

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Vasomotor
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pseudoephedrine
Ephedrine
Levocetirizine
Cetirizine
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
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents