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Completed

NCT Number: NCT00525382

Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria

Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.

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Key information

Conditions

Urticaria Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases

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 or female, 18 to 60 years old (inclusive
  • having chronic idiopathic urticaria
  • at least 6-weeks history of CIU, had at least 3 days of wheals presence/week
  • moderate to severe CIU defined as pruritus score ≥ 2, number of wheals ≥ 2, and total symptoms CIU score ≥ 2 at randomization

Exclusion criteria

  • Asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
  • atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or dermal topical corticosteroids
  • urticaria caused by physical factors or other known factors
  • cholinergic urticaria
  • had urticaria due to other systemic disorders
  • were on antihistamine drug currently

Treatment and study plan

levocetirizine dihydrochloride

Drug

Primary outcomes

  1. pruritus severity, assessed by the investigator over 2 weeks of treatment

    Time frame: 2 weeks

Secondary outcomes

  1. Symptom score reducing index; subject severity score at 1 and 2 weeks; investigator global evaluation after 2 weeks of treatment; safety

    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 Chronic Idiopathic Urticaria (CIU)

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 5, 2007
Registry last updated
Dec 12, 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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