Constipation associated with Parkinson's disease
Conditions
Interventions
Oral administration of naldemedine or placebo
Sponsors
Gomez - Juan Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 to under 75 at the time of obtaining the informed consent form (ICF). Patients diagnosed with Parkinson's disease with a Hoehn-Yahr severity classification of grade 1 to 3. Patients with no significant changes in bowel movements (frequency, etc.) during the 3 months prior to obtaining informed consent, and who rarely experience diarrhea unrelated to laxative use. Patients who experienced 5 or fewer spontaneous bowel movements (SBM ; a bowel movement without the use of a rescue laxative within the previous 24 hours) in the 2 weeks prior to the start of investigational drug administration, and who experienced straining, a feeling of incomplete evacuation, hard stools, or rabbit-pellet-like stools in 25% or more of their bowel movements during that period.
Exclusion criteria
Exclusion criteria: Patients whose primary cause of constipation is determined by the principal investigator (or co-investigator) to be other than Parkinson's disease. Patients who have not had a bowel movement in the week prior to obtaining informed consent or in the week prior to the start of investigational drug administration. Patients with gastrointestinal obstruction or suspected gastrointestinal obstruction, or patients with a history of gastrointestinal obstruction and a high risk of recurrence. Patients whose Parkinson's disease treatment has been changed within the 4 weeks prior to obtaining informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the number of SBMs within 24 hours after the first administration. | — |
Contacts
Public Contact- Corporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed