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

Information source: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vasomotor Rhinitis

Intervention: Pseudoephedrine / Levocetirizine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hanmi Pharmaceutical Company Limited

Official(s) and/or principal investigator(s):
Kyungmi Park, Ph.D., Study Director, Affiliation: Hanmi Pharmaceutical Company Limited

Summary

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

Clinical Details

Official title: Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: TVRSS(Total Vasomotor Rhinitis Symptom Score)

Secondary outcome: TVRSS, VRSS

Detailed description: randomized, double-blind, placebo-controlled, phase 3

Eligibility

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

ear, nose and throat, Boramae Hospital, Dongjak, Seoul 156-707, Korea, Republic of
Additional Information

Starting date: May 2011
Last updated: May 22, 2013

Page last updated: August 23, 2015

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