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

This study is currently recruiting participants.
Verified January 2012 by Hanmi Pharmaceutical Company Limited
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01509209
First received: January 10, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  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:

U.S. FDA Resources

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 chanage 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


Estimated Enrollment: 232
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 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 70 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509209

Contacts
Contact: Kyungmin LEE, Sr. CRA 82-2-410-9194 minimolly@hanmi.co.kr
Contact: Yoan PARK, Team Manager 82-2-410-8742 yapark@hanmi.co.kr

Locations
Korea, Republic of
ear, nose and throat, Boramae Hospital Recruiting
Dongjak, Seoul, Korea, Republic of, 156-707
Contact: Hong-Ryul Jin, M.D, PhD     82-2-870-2441     hrjin@snu.ac.kr    
Principal Investigator: Hong-Ryul Jin, M,D., Ph.D.            
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: January 10, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
vasomotor
pseudoephedirne
levocetirizine

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Vasomotor
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pseudoephedrine
Ephedrine
Levocetirizine
Cetirizine
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic 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 May 16, 2013