UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022023
Receipt number R000025378
Scientific Title A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora-
Date of disclosure of the study information 2016/05/10
Last modified on 2017/03/30 09:14:16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora-

Acronym

A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora-

Scientific Title

A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora-

Scientific Title:Acronym

A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora-

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 effect of intestinal bacterial flora 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

The percentage of good and bad bacteria jade in intestinal bacterial flora

Key secondary outcomes

The profile of intestinal bacterial flora


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are 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 microgrum (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 enrollmen

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 years and under 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

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

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 or person

Institute

Dokkyo Medical University

Institute

Department

Personal name



Funding Source

Organization

self-funding

Organization

Division

Category of Funding Organization

Self funding

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

Terminated

Date of protocol fixation

2016 Year 03 Month 08 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Some mistakes are founded in the reserch deesign in this study


Management information

Registered date

2016 Year 04 Month 21 Day

Last modified on

2017 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025378


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name