Parkinson'
Conditions
Interventions
8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium10 Capsules(once a day 2Cap,after breakfast) Blood concentration measurement dat
Sponsors
Utano National Hospital, National Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Parkinson's patients with wearing-off phenomenon taking L-DOPA formulation, there are gastrointestinal symptoms, the test sharing doctor determines that it is necessary the administration of the new proton pump inhibitors 2.Patients signed informed consent 3.Male and female patients aged 20 to 85 years old 4.Hoeho and Yahr stages 2 to 4 degrees at the off-time 5.Patients who themselves can fill out the symptom diary 6.Patients takeing levodopa+carbidopa(Menesit100 Tablets or DopacolL100 Tablets) 7.Patients who don't have a prescription change of anti-Parkinson's disease drugs including the L-DOPA formulation, during the period from the observation period up to the end of the study 8.Patients who can stop taking entacapone-containing drugs,from the time of waking up until the test is finished in the blood concentration measurement date
Exclusion criteria
Exclusion criteria: 1.Patients who can't take tablets and capsules 2.Patients after gastrectomy 3.Patients who are taking or within two weeks from final taking of H2-receptor antagonists and Proton pump inhibitors 4.Patients who need of administration of proton pump inhibitors in urgently 5.Patients with serious liver failure or renal dysfunction 6.Patients who have hypersensitivity to Nexium10 Capsules 7.Patients who take Combination contraindicated drugs with Nexium10 Capsules(Atazanavir Sulfate,Rilpivirine Hydrochloride) 8.Patients who have Lactose intolerance 9.Patients who are judged as unsuitable for the study by the investigator for the other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| L-DOPA blood concentration in blood collection point of before taking L-DOPA formulation and study drug, and after taking 10,20,30,45,60,90,120,240 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| UPDRS part3 Symptom diary | — |
Countries
Japan
Contacts
Public ContactYuri Yoshimura
Utano National Hospital, National Hospital Organization Department of Hospital Pharmacy
Outcome results
None listed