臨床研究等提出・公開システム

Date of registration	Nov. 21, 2016
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223387

Scientific Title	A Randomized, Parallel-Group, Double-Blind, Multicenter, Dose Equivalence Study of the Safety and Efficacy of Oral Lubiprostone in Subjects with Chronic Idiopathic Constipation
Public Title

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	Sucampo Pharma, LLC
	Address	03-3596-8011
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		134
Study Type		Interventional
Study Design	Study Design	Randomized, Parallel-Group, Double-Blind, Multicenter
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Subject has history of constipation, on average, less than 3 spontaneous bowel movements per week for at least 6 months before the start of screening and during the baseline period.
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Chronic Idiopathic Constipation
Intervention(s)		investigational material(s) Generic name etc : Lubiprostone INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : Two 12-mcg Lubiprostone capsules BID or one 24-mcg Lubiprostone capsule + one Placebo capsule BID.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Change from baseline in the frequency of spontaneous bowel movements at week 1
Secondary Outcome

Primary Sponsor	Sucampo Pharma, LLC
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-163442
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	April. 06, 2017	Detail	Changes
3	April. 06, 2017	Detail	Changes
2	Nov. 21, 2016	Detail	Changes
1	Nov. 21, 2016	Detail

List of change history