Parkinson disease Chronic constipation
Conditions
Interventions
Study drug group: A 12-week administration of lubiprostone 24 microgrum (adjustable) twice daily after switching from magnesium oxide
Control group: Continuous administration of magnesium oxide
Sponsors
Dokkyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of good and bad bacteria jade in intestinal bacterial flora | — |
Secondary
| Measure | Time frame |
|---|---|
| The profile of intestinal bacterial flora | — |
Countries
Japan
Contacts
Public ContactTomoyuki Uchiyama
Dokkyo Medical University Hospital Neurourology and Continence Center
Outcome results
None listed