CClinicalTrials.gg
CompletedNCT00520754Updated Dec 12, 2013

Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

A Phase 2 interventional study of levocetirizine dihydrochloride in Cough, sponsored by UCB Pharma. Completed. Open to participants aged 2 Months to 24 Months. Per ClinicalTrials.gov, last updated 2013-12-12.

Sponsored by UCB Pharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
2 Months to 24 Months
Sex
All
01

Study summary

Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

02

Conditions studied

  • Cough

Browse trials for

Keywords

  • levocetirizine dihydrochloride Xyzal tablets
03

In context

Cough

346 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's enrollment of 15 is below the median of 70 across 263 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • infants from 2 to 24 months both inclusive
  • suffering from recurrent cough associated with other allergic symptoms
  • hospitalized for respiratory or allergy related problems
  • laboratory results within normal ranges
  • height and weight between percentile 5 and 95

Exclusion criteria

Exclusion Criteria:

  • having taken any of the disallowed medication
  • suffering form any disorder
  • history of sleep apnea
  • having concomitant chronic disease
  • known relevant renal, hepatic, cardiac or metabolism dysfunction
  • known alcohol or drug addiction, severe psychiatric disease for the parent/guardian
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Interventions

  • Druglevocetirizine dihydrochloride
06

What researchers measure

Primary outcomes

  1. The efficacy based on daily record cards recordings

    Time frame: 90 days

Secondary outcomes

  1. Safety and pharmacokinetics at 90 days; skin reactivity

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Cranswick N, Turzikova J, Fuchs M, Hulhoven R. Levocetirizine in 1-2 year old children: pharmacokinetic and pharmacodynamic profile. Int J Clin Pharmacol Ther. 2005 Apr;43(4):172-7. doi: 10.5414/cpp43172. PubMed 15966463 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00520754
Lead sponsor
UCB Pharma
First posted
Aug 27, 2007
Start date
Dec 2001
Primary completion
Mar 2003
Completion
Mar 2003
Last update
Dec 12, 2013

Study contacts

UCB Clinical Trial Call Center
study director · UCB Pharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion