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

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.
 
ClinicalTrials.gov Identifier: NCT01509209
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : May 23, 2013
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Tracking Information
First Submitted Date  ICMJE January 10, 2012
First Posted Date  ICMJE January 12, 2012
Last Update Posted Date May 23, 2013
Study Start Date  ICMJE May 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
TVRSS(Total Vasomotor Rhinitis Symptom Score) [ Time Frame: 2week ]
the change from baseline in TVRSS
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01509209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2013)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
TVRSS, VRSS [ Time Frame: 1week or 2 week ]
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis
Official Title  ICMJE Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial
Brief Summary The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis
Detailed Description randomized, double-blind, placebo-controlled, phase 3
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vasomotor Rhinitis
Intervention  ICMJE Drug: Pseudoephedrine / Levocetirizine
tablet, BID everyday
Other Name: Cossac L
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: Pseudoephedrine / Levocetirizine
  • Experimental: Cossac L
    Pseudoephedrine 120mg + Levocetirizine 2.5mg
    Intervention: Drug: Pseudoephedrine / Levocetirizine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2013)
137
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2012)
232
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01509209
Other Study ID Numbers  ICMJE HM-LCT-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hanmi Pharmaceutical Company Limited
Study Sponsor  ICMJE Hanmi Pharmaceutical Company Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kyungmi Park, Ph.D. Hanmi Pharmaceutical Company Limited
PRS Account Hanmi Pharmaceutical Company Limited
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP