UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease
Acronym	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease
Scientific Title	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease
Scientific Title:Acronym	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease
Region	Japan

Condition
Condition	Parkinson disease Chronic constipation
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is intended to evaluate the efficacy, safety, quality of life, and dose adherence of lubiprostone (Amitiza) 24 or 48 microgrum in a 3-month administration for treatment of chronic constipation in patients with Parkinson disease after switching from magnesium oxide in comparison with patients continuously given treatment primarily with magnesium oxide for 3 months.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Score based on Constipation Scoring System (CSS)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Study drug group: A 12-week administration of lubiprostone 24 microrgrum (adjustable) twice daily after switching from magnesium oxide
Interventions/Control_2	Control group: Continuous administration of magnesium oxide at the same dosage regimen as before the enrollment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with Parkinson disease 2)Patients given a diagnosis of chronic constipation Chronic constipation shall be hereby defined as those with: 1.The mean frequency of spontaneous bowel movements is less than 3 per week for at least 6 months; 2.At least one of the following symptoms associated with spontaneous bowel movements for at least 6 months: a.Scybalum or hard stool at least once every 4 defecations, b.Incomplete bowel evacuation at least once every 4 defecations, or c.Straining at least once every 4 defecations; 3)Men and women aged over 20 years and under 90 years at the time of informed consent; 4)Inpatients or outpatients; 5)Patients continuously receiving magnesium oxide for over 4 weeks prior to the study commencement; 6)Patients who are able to consent in writing, comply with their responsibilities during the study, receive examinations and tests specified in the protocol, and report symptoms and other necessary information; and 7)Patients who agree to contraception use.
Key exclusion criteria	1)Patients with definitive or suspected mechanical obturation (intestinal obstruction attributable to tumor, hernia, etc.); 2)Patients with history of hypersensitivity to any of the ingredients of lubiprostone (Amitiza); 3)Patients with serious cardiovascular disease, lung disease, liver disease, renal disease, digestive disorder, neurological disorder, or psychiatric disorder (including pre-existing alcohol or drug abuse), or patients with a systemic disease; 4)Women who are pregnant, breast-feeding, or seeking to conceive or may conceive due to improper contraception method during the study period; 5)Patients receiving nonpharmacologic therapy within 4 weeks prior to the study commencement, which may influence the bowel movement; 6)Patients who received an investigational drug in other clinical study within 1 month prior to the study commencement (the period of which should be calculated based on the date on which the investigational drug was administered); 7)Patients who are otherwise ineligible to take part in the study as judged by Principal Investigator or other relevant person; or 8)Patients who meet the criteria concerning prohibited or restricted concomitant medications (i.e., drugs of the same class, or with interactions, etc.). 9)Patients with diarrhea 10)Patients of hypermagnesemia
Target sample size	64

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Tomoyuki Uchiyama
Organization	Dokkyo Medical University Hospital
Division name	Neurourology and Continence Center
Zip code
Address	880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL	0282-86-1111
Email	t-uchi@dokkyomed.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Tomoyuki Uchiyama
Organization	Dokkyo Medical University Hospital
Division name	Neurourology and Continence Center
Zip code
Address	880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL	0282-86-1111
Homepage URL
Email	t-uchi@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Mylan EPD LLC (based on an academia-initiated joint study agreement)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 08 Day
Date of IRB	2016 Year 03 Month 08 Day
Anticipated trial start date	2016 Year 05 Month 10 Day
Last follow-up date	2017 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 04 Month 21 Day
Last modified on	2019 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025377