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
- Conditions
- Parkinson disease Chronic constipation
- Registration Number
- JPRN-UMIN000022023
- Lead Sponsor
- Dokkyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 64
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method