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Completed

NCT Number: NCT00524836

Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis

Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis.

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Key information

Conditions

Rhinitis Allergic Infections Nose Diseases Otorhinolaryngologic Diseases Perennial Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male ore female, 16 to 60 years old (inclusive)
  • two-year history of allergic rhinitis due to house dust mite

Exclusion criteria

  • An ear, nose or throat (ENT) infection
  • asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
  • atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
  • an associated ENT disease
  • use of decongestants
  • nasal or ocular topical treatment
  • desensitivation

Treatment and study plan

levocetirizine dihydrochloride

Drug

Primary outcomes

  1. Total 5 Symptom Score (T5SS) rated by the investigator

    Time frame: 2 weeks

Secondary outcomes

  1. Investigators global efficacy evaluation at the end of treatment; subject's rating of T5SS and individual symptoms (over the last 24 hours) over first week and the total 2 weeks treatment period; the Symptoms Score Reducing Index (SSRI).

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Perennial Allergic Rhinitis.

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 5, 2007
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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