A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000022022
• Date of registration: 10/05/2016
• Prospective Registration: Yes
• Primary sponsor: Dokkyo Medical University
• Public title: 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 - A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease
• Date of first enrolment: 2016/05/10
• Target sample size: 64
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025377
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Tomoyuki Uchiyama
• Affiliation: Dokkyo Medical University Hospital Neurourology and Continence Center

• Name: Tomoyuki Uchiyama
• Affiliation: Dokkyo Medical University Hospital Neurourology and Continence Center

Key inclusion & exclusion criteria

Inclusion 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

Age minimum: 20years-old
Age maximum: 90years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Parkinson disease Chronic constipation

Intervention(s)

Study drug group: A 12-week administration of lubiprostone 24 microrgrum (adjustable) twice daily after switching from magnesium oxide
Control group: Continuous administration of magnesium oxide at the same dosage regimen as before the enrollment

Primary Outcome(s)

Score based on Constipation Scoring System (CSS)

Source(s) of Monetary Support

Mylan EPD LLC (based on an academia-initiated joint study agreement)

Ethics review

Status: YES
Approval date: 08/03/2016
Contact:

Results

• Results available: Yes
• Date Completed: 31/07/2017