AzTrials
AzTrials

Rhinitis, Allergic, PerennialPhase 3NCT00490204

Cetirizine Placebo Controlled Study For Perennial Allergic Rhinitis

A Phase 3 study testing Cetirizine in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 28 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 14 years
Conditions the study is for
Rhinitis, Allergic, Perennial
What is being tested?
Cetirizine
How many people
239 participants
Where
28 sitesJapan
Study dates
27 Jul 2007to 3 Oct 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • [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.
Show all 28Show fewer
  • 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

Who cannot join

  • "[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.
Show all 33Show fewer
  • 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]
  • 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."

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Japan28 sites

  • GSK Investigational Site

    Chiba, 277-0882

  • GSK Investigational Site

    Fukuoka, 807-0856

  • GSK Investigational Site

    Fukuoka, 811-1201

  • GSK Investigational Site

    Fukuoka, 819-0002

  • GSK Investigational Site

    Hokkaido, 001-0923

  • GSK Investigational Site

    Hokkaido, 007-0840

  • GSK Investigational Site

    Hokkaido, 053-0833

  • GSK Investigational Site

    Hokkaido, 061-1133

  • GSK Investigational Site

    Hokkaido, 061-1448

  • GSK Investigational Site

    Hokkaido, 062-0034

  • GSK Investigational Site

    Kanagawa, 212-0027

  • GSK Investigational Site

    Kanagawa, 213-0011

  • GSK Investigational Site

    Kanagawa, 216-0002

  • GSK Investigational Site

    Kanagawa, 222-0011

  • GSK Investigational Site

    Kanagawa, 224-0003

  • GSK Investigational Site

    Kanagawa, 232-0056

  • GSK Investigational Site

    Kumamoto, 862-0952

  • GSK Investigational Site

    Kumamoto, 862-0962

  • GSK Investigational Site

    Ōita, 870-0021

  • GSK Investigational Site

    Saitama, 333-0861

  • GSK Investigational Site

    Saitama, 336-0022

  • GSK Investigational Site

    Saitama, 350-1205

  • GSK Investigational Site

    Saitama, 355-0062

  • GSK Investigational Site

    Shizuoka, 420-0803

  • GSK Investigational Site

    Shizuoka, 422-8066

  • GSK Investigational Site

    Shizuoka, 436-0058

  • GSK Investigational Site

    Tokyo, 157-0067

  • GSK Investigational Site

    Tokyo, 170-0005

Other trials in Japan

About this study

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.

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.

Being tested
Cetirizine
Keywords
Perennial Allergic Rhinitis, Placebo control, anti-histamine, Cetirizine
Medical subject headings
Rhinitis, Allergic, Perennial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetirizineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From Baseline to Day 14

Secondary outcomes (6)

  1. Changes in TNSS on the first and the second weeks of the 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 at Week 1 and Week 2.

    Measured: From Baseline to Day 7 and Day 14

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

    Each nasal symptom score for sneezing, rhinorrhea, nasal congestion and nasal itching is scored on a scale from 0 to 3; the larger score indicates more severe symptoms. The parent/guardian or the participant scored nasal symptoms every day.

    Measured: From Baseline to Day 14

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

    TDNSS is a sum of the daily nasal symptom score for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is score on a scale from 0 to 3; the range of sums for TDNSS is 0 to 12; a larger score indicates more severe symptoms.

    Measured: From Baseline to Day 14

  4. 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)

    The investigator evaluated the participant's improvement rating (defined as improvement in the symptoms of rhinitis compared with Baseline), using the following 5 categories: significantly improved, moderately improved, mildly improved, unchanged, and worsened.

    Measured: Day 8 and Day 15 or DC

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

    The participant's parent/guardian or the participant evaluated the participant's improvement rating (defined as improvement in the symptoms of rhinitis compared with Baseline), using the following 7 categories: significantly improved, improved, slightly improved, unchanged, slightly worsened, worsened, and significantly worsened.

    Measured: Day 8 and Day 15 or DC

  6. Changes in each rhinoscopy finding (swelling and color of inferior conchal mucosa and aqueous secretion volume (ASV)) on first day of Treatment Week 1 (Day 1), the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15) or at DC

    Rhinoscopy was assessed by the investigator by scoring swelling of inferior conchal mucosa scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 1 and 3), or 3 (impossible to see middle turbinate); color of inferior conchal mucosa scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); aqueous secretion volume (vol) scored as 0 (none), 1 (small amount adhered), 2 (between 1 and 3), or 3 (filled).

    Measured: Day 1, Day 8 and Day 15 or DC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2007 (estimated)
  2. Study start27 Jul 2007
  3. Primary completion3 Oct 2007
  4. Study completion3 Oct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00490204
Sponsor's protocol ID
110458
Status last verified
Aug 2017
First submitted
19 Jun 2007
Last updated
29 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cetirizine in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 28 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the total nasal symptom score (TNSS) during the total treatment period from the baseline (time frame: From Baseline to Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00490204.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in