Achondroplasia FGFR3, Short stature
Conditions
Interventions
Sponsors
Matsushita Masaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have been confirmed to Definite or Probable among the achondroplasia diagnostic criteria created by the Intractable Diseases Research Group of the Ministry of Health, Labor and Welfare more than one year before obtaining consent. 2) Patients whose age at the time of obtaining consent is 5 to 11 years old. 3) Patients who can be hospitalized on the last administration day and are expected to complete this clinical trial. 4) Patients whose consent was obtained in writing by the substitute. 5) If the subject is 7 years old or older, the patient who obtained the ascent in writing from the subject. 6) Patients who can take tablets .
Exclusion criteria
Exclusion criteria: 1) Patients who took a drug containing meclizine hydrochloride within 28 days before the start of administration. 2) Patients who have undergone bone lengthening within 28 days before the start of administration or who are planning to perform bone lengthening during the study period. 3) Patients with serious complications. 4) Patients weighting less than 11 kg. 5) Patients with symptoms of difficulty urinating. 6) Patients diagnosed with glaucoma. 7) Patients with allergies to meclizine hydrochloride. 8) Patients who regularly take oral medicines containing cold medicine, antipyretic analgesic, sedative, antitussive expectorant, and antihistamine. 9) Patients who are judged to be inappropriate for conducting this clinical trial by the principal investigator or co-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events up to 21 days after the first dose 2. Pharmacokinetic parameters (Tmax, Cmax, AUC, t1 / 2) | — |
Contacts
Public ContactYasuhiro Nakai
Nagoya University Hospital
Outcome results
None listed