Last updated: 11/03/2018 11:02:52
Cetirizine Placebo Controlled Study For Perennial Allergic Rhinitis
GSK study ID
110458
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Change in the total nasal symptom score (TNSS) during the total treatment period from the baseline
Timeframe: From Baseline to Day 14
Secondary outcomes:
Changes in TNSS on the first and the second weeks of the treatment period from the baseline
Timeframe: From Baseline to Day 7 and Day 14
Mean scores for each nasal symptom and the time-course changes for the scores
Timeframe: From Baseline to Day 14
Time-course changes in a total of daily mean nasal symptom scores (TDNSS)
Timeframe: 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)
Timeframe: 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
Timeframe: Day 8 and Day 15 or DC
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
Timeframe: Day 1, Day 8 and Day 15 or DC
Interventions:
Drug: Cetirizine
Enrollment:
239
Observational study model:
Not applicable
Primary completion date:
2007-03-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Rhinitis, Allergic, Perennial
Product
cetirizine
Collaborators
Not applicable
Study date(s)
July 2007 to October 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
2 - 14 years
Accepts healthy volunteers
No
- [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.
- "[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.
Inclusion and exclusion 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).
- 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
Children administered the following drugs within one week (6days) or 4 weeks (27days) before the start of the observation period [within one week]
Exclusion criteria:
- 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."
"[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]
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-03-10
Actual study completion date
2007-03-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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