臨床研究等提出・公開システム

Date of registration	April. 14, 2015
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222818

Scientific Title	A phase III parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPA
Public Title	A parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPA

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Hisamitsu Pharmaceutical Co., Inc.
	Address	sodanshitsu@hisamitsu.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Multicenter, randomized, double-blind, parallel group comparison study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	- Patients diagnosed with Parkinson's disease in stages 2 to 4 on the modified Hoehn & Yahr scale("on" time).
	Exclusion Criteria	- Patients with a history of hypersensitivity to ropinirole. - Patients with clinically significant renal impairment or hepatic dysfunction. - Patients who have any cutaneous abnormality at the planned application site that could be aggravated by application of the investigational product.
	Minimum Age	20age old over
	Maximum Age	79age old under
	Gender	Both
Health Condition or Problem Studied		Parkinson's disease
Intervention(s)		investigational material(s) Generic name etc : HP-3000 (ropinirole hydrochloride patch) INN of investigational material : Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational material : Transdermal, once daily control material(s) Generic name etc : HP-3000 placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Transdermal, once daily Generic name etc : Ropinirole hydrochloride extended-release tablet INN of investigational material : Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational material : Oral, once daily Generic name etc : Ropinirole hydrochloride extended-release tablet placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral, once daily
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy, and safety.
Secondary Outcome

Primary Sponsor	Hisamitsu Pharmaceutical Co.,Inc.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-152870
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	July. 24, 2018	Detail	Changes
3	July. 24, 2018	Detail	Changes
2	April. 14, 2015	Detail	Changes
1	April. 14, 2015	Detail

List of change history