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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01509209
First received: January 10, 2012
Last updated: May 22, 2013
Last verified: May 2013
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    the change from baseline in TVRSS


Secondary Outcome Measures:
  • TVRSS, VRSS [ Time Frame: 1week or 2 week ] [ Designated as safety issue: No ]
    • 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

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01509209     History of Changes
Other Study ID Numbers: HM-LCT-301
Study First Received: January 10, 2012
Last Updated: May 22, 2013
Health Authority: Korea: Food and Drug Administration

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
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Stimulants
Central Nervous System Agents
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists

ClinicalTrials.gov processed this record on September 30, 2014