Clinical trial NCT02182544 (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: wal801cl dry syrup, ketotifen fumarate dry syrup, ketotifen fumarate dry syrup placebo, wal 801 cl dry syrup placebo
SMILES: CN1CCC(CC1)=C1C2=C(SC=C2)C(=O)CC2=CC=CC=C12, CN1CCC(CC1)=C1C2=C(SC=C2)C(=O)CC2=CC=CC=C12, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  15 years of age or younger

          -  Body weight of 14 kg or more

          -  Typical symptoms of perennial allergic rhinitis, and within 2 or higher score of serum
             specific immunoglobulin E (IgE) caused by house dust (HD) or mite in the data obtained
             with the past one year

          -  "Moderate" or "Severe" in the Allergic Rhinitis Severity Classification during the
             observation period

          -  The Patient Diary can be entered by the patient or parent

          -  Outpatients

        Exclusion Criteria:

          -  Absolute necessity of treatment with a drug that may affect the evaluation of the
             effect of the investigational drug (e.g., anti-histamines, anti-allergics, steroid,
             vasopressors). Patients being treated with the following drugs, however, may be
             included

               -  Intal® Oral or Inhalation

               -  Any eye drops other than Zaditen® Eye Drop

               -  External preparations (liniment, poultice)

          -  Initiation of desensitisation therapy within the past 6 months

          -  Onset of acute upper respiratory inflammation during the observation period

          -  Nasal disease, such as acute or chronic rhinitis, nasal polyp, hypertrophic rhinitis,
             septal deviation*, sinusitis*, and hypertrophied adenoid*, of such a degree that the
             disease affects evaluation of the effect of the test drug (*: X-ray examination will
             be conducted if necessary)

          -  That pollen (cider, ragweed, Japanese cypress, orchard grass, etc.) is a double
             antigen, and that the study will be conducted in the season of air-borne pollen, and
             symptoms may be exacerbated by pollen

          -  Present or past history of a convulsive disease, such as epilepsy (convulsion
             threshold values may be decreased by the comparator drug, ketotifen fumarate)

          -  Clinically significant abnormal changes in laboratory measurements, and thus judgement
             that the patient is ineligible for inclusion in this study; however, if the patient is
             judged as falling into Grade 2 or more according to the MHW (Ministry of health and
             welfare) Adverse Reaction Severity Classification Criteria, the patient will be
             excluded from the study

          -  Clinically significant renal, hepatic or cardiac disease, or other complications, and
             thus judgement that the patient is ineligible for inclusion in the study; however, if
             the patient is judged as falling into Grade 2 or more according to the MHW Adverse
             Reaction Severity Classification Criteria, the patient will be excluded from the study

          -  Past history of drug allergy

          -  1 month, or 6 times as long as the half life of the investigational drug if it is over
             1 month, will not have passed since participation in any other clinical trial study,
             at the time of the initiation of this study

          -  Judgement by the Principal Investigator or Investigator that the patient is ineligible
             for inclusion in this study