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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

January 10, 2012
May 22, 2013
May 2011
April 2013   (final data collection date for primary outcome measure)
TVRSS(Total Vasomotor Rhinitis Symptom Score) [ Time Frame: 2week ] [ Designated as safety issue: No ]
the change from baseline in TVRSS
Same as current
Complete list of historical versions of study NCT01509209 on ClinicalTrials.gov Archive Site
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
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
Not Provided
Not Provided
 
Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis
Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial

The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis

randomized, double-blind, placebo-controlled, phase 3

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vasomotor Rhinitis
Drug: Pseudoephedrine / Levocetirizine
tablet, BID everyday
Other Name: Cossac L
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: Pseudoephedrine / Levocetirizine
  • Experimental: Cossac L
    Pseudoephedrine 120mg + Levocetirizine 2.5mg
    Intervention: Drug: Pseudoephedrine / Levocetirizine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
12 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01509209
HM-LCT-301
No
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Study Director: Kyungmi Park, Ph.D. Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
May 2013

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