NCT00490204

Brief Summary

Study objective is to verify the superiority of CTZ DS to the placebo groups in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

July 27, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2007

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

June 19, 2007

Last Update Submit

August 28, 2017

Conditions

Rhinitis, Allergic, Perennial

Keywords

Perennial Allergic RhinitisPlacebo controlanti-histamineCetirizine

Outcome Measures

Primary Outcomes (1)

  • Change in the total nasal symptom score (TNSS) during the total treatment period from the baseline

    TNSS is a sum of the nasal symptom score for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The Baseline value is defined as the average TNSS over the last 3 consecutive days prior to Day 1. For total treatment period, the average TNSS for each participant was calculated using available diary data from the total treatment period, taking the average of non-missing data during the period. Change from Baseline was calculated as the score at Baseline minus the mean score for the total treatment period.

    From Baseline to Day 14

Secondary Outcomes (6)

  • Changes in TNSS on the first and the second weeks of the treatment period from the baseline

    From Baseline to Day 7 and Day 14

  • Mean scores for each nasal symptom and the time-course changes for the scores

    From Baseline to Day 14

  • Time-course changes in a total of daily mean nasal symptom scores (TDNSS)

    From Baseline to Day 14

  • Investigator global improvement rating on the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15 ) or at discontinuation (DC)

    Day 8 and Day 15 or DC

  • Participant global improvement rating on the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15) or at DC

    Day 8 and Day 15 or DC

  • +1 more secondary outcomes

Interventions

CetirizineDRUG

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- \[Before the start of observation period\]
  • Children with a history of hypersensitivity to an ingredient of cetirizine hydrochloride preparation, or hydroxyzine, cyclizine, meclozine, buclizine.
  • Children with a history of drug hypersensitivity.
  • Pregnant, lactating or possibly pregnant female children.
  • Children with complications that may be clinically significant (e.g., hepatic disorder, renal disorder, heart disease or others) because of which they are judged as inappropriate for this trial.
  • Children who are sensitive to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods.
  • Children with vasomotor rhinitis and eosinophilic rhinitis.
  • Children complicated with a nasal disorder (e.g., acute or chronic rhinitis, hypertrophic rhinitis, acute or chronic sinusitis, deviation of nasal septum, nasal polyp, etc.) with a degree that may influence on the evaluation of the study drugs.
  • Children complicated with asthma that requires the treatment with adrenocortical hormone (including the preparations compounded with adrenocortical hormone).
  • Children administered the following drugs within one week (6days) or 4 weeks (27days) before the start of the observation period \[within one week\] • Anti-histamine drugs (oral, injection, and nasal drop) • Chemical mediator release inhibitors (mast cell stabilizer) • Th2 cytokine inhibitors (suplatast tosilate) • Leukotriene receptor antagonists • Thromboxane A2 receptor antagonists
  • Thromboxane synthetase inhibitors
  • Biological preparations and vaccines indicated against allergic rhinitis
  • Vasoconstrictor(oral and nasal drop)
  • Anticholinergic drugs (inhalant only)
  • General cold remedies (including OTC)
  • +12 more criteria

You may not qualify if:

  • "\[Before the start of observation period\]
  • Children with a history of hypersensitivity to an ingredient of cetirizine hydrochloride preparation, or hydroxyzine, cyclizine, meclozine, buclizine.
  • Children with a history of drug hypersensitivity.
  • Pregnant, lactating or possibly pregnant female children.
  • Children with complications that may be clinically significant (e.g., hepatic disorder, renal disorder, heart disease or others) because of which they are judged as inappropriate for this trial.
  • Children who are sensitive to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods.
  • Children with vasomotor rhinitis and eosinophilic rhinitis.
  • Children complicated with a nasal disorder (e.g., acute or chronic rhinitis, hypertrophic rhinitis, acute or chronic sinusitis, deviation of nasal septum, nasal polyp, etc.) with a degree that may influence on the evaluation of the study drugs.
  • Children complicated with asthma that requires the treatment with adrenocortical hormone (including the preparations compounded with adrenocortical hormone).
  • Children administered the following drugs within one week (6days) or 4 weeks (27days) before the start of the observation period \[within one week\]
  • Anti-histamine drugs (oral, injection, and nasal drop)
  • Chemical mediator release inhibitors (mast cell stabilizer)
  • Th2 cytokine inhibitors (suplatast tosilate)
  • Leukotriene receptor antagonists
  • Thromboxane A2 receptor antagonists
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

GSK Investigational Site

Chiba, 277-0882, Japan

Location

GSK Investigational Site

Fukuoka, 807-0856, Japan

Location

GSK Investigational Site

Fukuoka, 811-1201, Japan

Location

GSK Investigational Site

Fukuoka, 819-0002, Japan

Location

GSK Investigational Site

Hokkaido, 001-0923, Japan

Location

GSK Investigational Site

Hokkaido, 007-0840, Japan

Location

GSK Investigational Site

Hokkaido, 053-0833, Japan

Location

GSK Investigational Site

Hokkaido, 061-1133, Japan

Location

GSK Investigational Site

Hokkaido, 061-1448, Japan

Location

GSK Investigational Site

Hokkaido, 062-0034, Japan

Location

GSK Investigational Site

Kanagawa, 212-0027, Japan

Location

GSK Investigational Site

Kanagawa, 213-0011, Japan

Location

GSK Investigational Site

Kanagawa, 216-0002, Japan

Location

GSK Investigational Site

Kanagawa, 222-0011, Japan

Location

GSK Investigational Site

Kanagawa, 224-0003, Japan

Location

GSK Investigational Site

Kanagawa, 232-0056, Japan

Location

GSK Investigational Site

Kumamoto, 862-0952, Japan

Location

GSK Investigational Site

Kumamoto, 862-0962, Japan

Location

GSK Investigational Site

Ōita, 870-0021, Japan

Location

GSK Investigational Site

Saitama, 333-0861, Japan

Location

GSK Investigational Site

Saitama, 336-0022, Japan

Location

GSK Investigational Site

Saitama, 350-1205, Japan

Location

GSK Investigational Site

Saitama, 355-0062, Japan

Location

GSK Investigational Site

Shizuoka, 420-0803, Japan

Location

GSK Investigational Site

Shizuoka, 422-8066, Japan

Location

GSK Investigational Site

Shizuoka, 436-0058, Japan

Location

GSK Investigational Site

Tokyo, 157-0067, Japan

Location

GSK Investigational Site

Tokyo, 170-0005, Japan

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Cetirizine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 22, 2007

Study Start

July 27, 2007

Primary Completion

October 3, 2007

Study Completion

October 3, 2007

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

JP(28)