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

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Hanmi Pharmaceutical

Status and phase

Completed
Phase 3

Conditions

Vasomotor Rhinitis

Treatments

Drug: Pseudoephedrine / Levocetirizine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01509209
HM-LCT-301

Details and patient eligibility

About

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

Full description

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

Enrollment

137 patients

Sex

All

Ages

12 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

137 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
placebo
Treatment:
Drug: Pseudoephedrine / Levocetirizine
Cossac L
Experimental group
Description:
Pseudoephedrine 120mg + Levocetirizine 2.5mg
Treatment:
Drug: Pseudoephedrine / Levocetirizine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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