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 |
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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
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
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
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
