Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000022529
• Date of registration: 01/06/2016
• Prospective Registration: Yes
• Primary sponsor: Utano National Hospital, National Hospital Organization
• Public title: Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease
• Scientific title: Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease - Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease
• Date of first enrolment: 2016/06/01
• Target sample size: 8
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025614
• Study type: Interventional
• Study design: Cross-over Randomized
• Phase: Phase III

Countries of recruitment

Japan

Contacts

• Name: Yuri Yoshimura
• Affiliation: Utano National Hospital, National Hospital Organization Department of Hospital Pharmacy

• Name: Munehiro Yoshino
• Affiliation: Utano National Hospital, National Hospital Organization Department of Hospital Pharmacy

Key inclusion & exclusion criteria

Inclusion 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

Age minimum: 20years-old
Age maximum: 85years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Parkinson's disease

Intervention(s)

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 date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg) Washout 6days 8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap
8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast) Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap Washout 6days 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 date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg)

Primary Outcome(s)

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 Outcome(s)

UPDRS part3 Symptom diary

Source(s) of Monetary Support

None

Ethics review

Status: YES
Approval date:
Contact: