CClinicalTrials.gg
CompletedNCT00257582Updated May 6, 2013

Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics

A Phase 3 interventional study of Cetirizine Dry Syrup in Pruritus, sponsored by GlaxoSmithKline. Completed at 1 site. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2013-05-06.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
2 Years to 14 Years
Sex
All
01

Study summary

To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.

02

Conditions studied

  • Pruritus

Browse trials for

Keywords

  • cetirizine
  • various type of cutaneous disease accompanied with Pruritus
  • pediatrics
03

In context

Pruritus

354 studies on the registry are indexed under Pruritus; 74 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 294 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

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

04

Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic urticaria
  • Eczema \& dermatitis group
  • Atopic dermatitis
  • Prurigo group: Acute prurigo, Prurigo subacuta, Chronic prurigo
  • Pruritus cutaneous: Systemic pruritus cutaneous, Topical pruritus cutaneous
  • Giving informed consent
  • Children who have 2 grades or more pruritus score when assessed by the investigator or sub-investigator with the criteria for the diurnal or nocturnal pruritus score in the patient diary.
  • Children with a pruritus severity of "2.Mild" or severer on the first day of the treatment period.

Exclusion criteria

Exclusion criteria:

  • have a history of drug hypersensitivity
  • are pregnant, lactating or possibly pregnant female children.
  • have asthma that requires the treatment with corticosteroid.
  • cannot avoid the use of external steroid classified into "strong", "strongest" or "very strong".
  • have pruritus only on face and head.
  • have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug.
  • are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants

Interventions

  • DrugCetirizine Dry Syrup
06

What researchers measure

Primary outcomes

  1. To assess the safety

Secondary outcomes

  1. -severity of pruritus -total pruritus score -daily main prurutus score -Severity of eruption -Patient global Improvement rating -Body temperature -Adverse events -Cetirizine serum concentrations

07

Study locations

1 site
  • GSK Investigational Site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00257582
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 23, 2005
Start date
Aug 2005
Last update
May 6, 2013

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2013. 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