Cetirizine Placebo Controlled Study For Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00490204
First received: June 19, 2007
Last updated: May 21, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: Cetirizine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled Study for Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup (CTZ DS) (2.5 mg or 5 mg Twice a Day) in Children (2 Years of Age or Older But Under 15 Years Old) Suffering From Perennial Allergic Rhinitis.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The primary efficacy endpoint is a change in the total nasal symptom score (TNSS) during the total treatment period from the baseline assessment period.

Secondary Outcome Measures:
  • (4) Investigator global improvement rating on the first day of Treatment Week 2 (D8) and the final observation day (D15) or at discontinuation.
  • (5) Patient global improvement rating on the first day of Treatment Week 2 (D8) and the final observation day (D15) or at discontinuation..
  • 6) Changes in each nasal finding (swelling and color of inferior conchal mucosa and aqueous secretion volume observed by rhinoscopy) on the first day of Treatment Week 1 (D1), the first day of Treatment Week 2 (D8) and final observation day (D15)
  • 2) Evaluation of the safety To assess and compare the safety between the 2 groups thorough the trial. 3) Evaluation of Pharmacokinetics
  • To determine serum CTZ concentration on the first day of Treatment Week 2 (D8) and the final observation day (D15) or at discontinuation to investigate the pharmacokinetics in the population of children.
  • Efficacy Weekly total nasal symptom score (TNSS). Each nasal symptom.Total daily nasal symptom score/TDNS.Investigator global improvement rating/ patient global improvement rating.Nasal findings. Safety
  • 1) Evaluation of the efficacy: To assess the efficacy of CTZ DS in comparison with placebo in the following items (1) Changes in TNSS on the first and the second weeks of the treatment period from the score of the baseline assessment period.
  • (2) Mean scores for each nasal symptom and the time-course changes for the scores. (3) Time-course changes in a total of daily mean nasal symptom scores (TDNSS).

Estimated Enrollment: 236
Study Start Date: July 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cetirizine
    Other Name: Cetirizine
  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

- [Before the start of observation period]

  1. 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)

      • Herb medicines that have antiallergic action (SHOSEIRYUTO, SHOSAIKOTO, SAIBOKUTO, etc.)

      • OTC anti-rhinitis drugs (oral, inhalant, nasal drop) [within 4 weeks]

      • Adrenocortical hormones (oral [including combination drugs], injection, inhalant, nasal drop, suppository)

      • Histamine added γ-globulin preparations

    • Children who have started specific desensitization treatment or nonspecific modulation treatment but who have not reached the maintenance level of treatment.
    • Children who have received surgical treatment for reduction and modulation of nasal mucosa, redintegration therapy of nasal cavity to improve the degree of nasal airway, or surgical operation to improve rhinorrhea.
    • Children who have previously taken the investigational products of this trial.
    • Children who have participated in other clinical trial within 6 months of the date of informed consent for this clinical study or children who are participating in another trial as of the date of informed consent for this trial.
    • Children judged by the investigator or sub-investigator as inappropriate to participate in the trial.

[Before the start of treatment period] - Children whose severity score calculated by the following formula on the basis of nasal symptom score (sneezing, rhinorrhea, nasal pruritus and nasal congestion) in the baseline assessment period (3 days from D5 to D7) is 10 or higher Severity of TNSS = [TDNSS(D-3)+TDNSS(D-2)+TDNSS(D-1)]/3

  • Children who have used prohibited concomitant drugs during the observation period.
  • Children who have complicated acute upper airway inflammation during the observation period.
  • Children who are applicable to the exclusion criteria as to the status [before the start of observation period] during the observation period." gher

Exclusion criteria:

"[Before the start of observation period]

  1. Children with a history of hypersensitivity to an ingredient of cetirizine hydrochloride preparation, or hydroxyzine, cyclizine, meclozine, buclizine.
  2. Children with a history of drug hypersensitivity.
  3. Pregnant, lactating or possibly pregnant female children.
  4. 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.
  5. Children who are sensitive to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods.
  6. Children with vasomotor rhinitis and eosinophilic rhinitis.
  7. 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.
  8. Children complicated with asthma that requires the treatment with adrenocortical hormone (including the preparations compounded with adrenocortical hormone).
  9. 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)

    • Herb medicines that have antiallergic action (SHOSEIRYUTO, SHOSAIKOTO, SAIBOKUTO, etc.)

    • OTC anti-rhinitis drugs (oral, inhalant, nasal drop) [within 4 weeks]
    • Adrenocortical hormones (oral [including combination drugs], injection, inhalant, nasal drop, suppository)
    • Histamine added γ-globulin preparations
  10. Children who have started specific desensitization treatment or nonspecific modulation treatment but who have not reached the maintenance level of treatment.
  11. Children who have received surgical treatment for reduction and modulation of nasal mucosa, redintegration therapy of nasal cavity to improve the degree of nasal airway, or surgical operation to improve rhinorrhea.
  12. Children who have previously taken the investigational products of this trial.
  13. Children who have participated in other clinical trial within 6 months of the date of informed consent for this clinical study or children who are participating in another trial as of the date of informed consent for this trial.
  14. Children judged by the investigator or sub-investigator as inappropriate to participate in the trial.

[Before the start of treatment period]

1) Children whose severity score calculated by the following formula on the basis of nasal symptom score (sneezing, rhinorrhea, nasal pruritus and nasal congestion) in the baseline assessment period (3 days from D5 to D7) is 10 or higher Severity of TNSS = [TDNSS(D-3)+TDNSS(D-2)+TDNSS(D-1)]/3 2) Children who have used prohibited concomitant drugs during the observation period.

3) Children who have complicated acute upper airway inflammation during the observation period.

4) Children who are applicable to the exclusion criteria as to the status [before the start of observation period] during the observation period."

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490204

Locations
Japan
GSK Investigational Site
Chiba, Japan, 277-0882
GSK Investigational Site
Fukuoka, Japan, 807-0856
GSK Investigational Site
Fukuoka, Japan, 811-1201
GSK Investigational Site
Fukuoka, Japan, 819-0002
GSK Investigational Site
Hokkaido, Japan, 061-1133
GSK Investigational Site
Hokkaido, Japan, 053-0833
GSK Investigational Site
Hokkaido, Japan, 001-0923
GSK Investigational Site
Hokkaido, Japan, 007-0840
GSK Investigational Site
Hokkaido, Japan, 062-0034
GSK Investigational Site
Hokkaido, Japan, 061-1448
GSK Investigational Site
Kanagawa, Japan, 212-0027
GSK Investigational Site
Kanagawa, Japan, 224-0003
GSK Investigational Site
Kanagawa, Japan, 222-0011
GSK Investigational Site
Kanagawa, Japan, 232-0056
GSK Investigational Site
Kanagawa, Japan, 216-0002
GSK Investigational Site
Kanagawa, Japan, 213-0011
GSK Investigational Site
Kumamoto, Japan, 862-0952
GSK Investigational Site
Kumamoto, Japan, 862-0962
GSK Investigational Site
Oita, Japan, 870-0021
GSK Investigational Site
Saitama, Japan, 350-1205
GSK Investigational Site
Saitama, Japan, 333-0861
GSK Investigational Site
Saitama, Japan, 336-0022
GSK Investigational Site
Saitama, Japan, 355-0062
GSK Investigational Site
Shizuoka, Japan, 420-0803
GSK Investigational Site
Shizuoka, Japan, 436-0058
GSK Investigational Site
Shizuoka, Japan, 422-8066
GSK Investigational Site
Tokyo, Japan, 170-0005
GSK Investigational Site
Tokyo, Japan, 157-0067
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00490204     History of Changes
Other Study ID Numbers: 110458
Study First Received: June 19, 2007
Last Updated: May 21, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Cetirizine
Perennial Allergic Rhinitis
Placebo control
anti-histamine

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014