Clinical trial NCT00490204 (phase 3, status: completed)
Conditions: rhinitis, allergic, perennial
ICD codes: J30.0, J31.0, J30.89, J30.9, A50.05, J30.2, J30.1
Drugs: cetirizine
SMILES: OC(=O)COCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1
Eligibility 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."