Actively Recruiting
Tenapanor in Synucleinopathy-Related Constipation
Led by Cedar Valley Digestive Health Center · Updated on 2025-02-10
30
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
Sponsors
C
Cedar Valley Digestive Health Center
Lead Sponsor
A
Ardelyx
Collaborating Sponsor
AI-Summary
What this Trial Is About
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
CONDITIONS
Official Title
Tenapanor in Synucleinopathy-Related Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 to 89 years
- Diagnosis of Parkinson's disease within Hoehn and Yahr stages 1 to 3, confirmed by a neurologist using International Parkinson and Movement Disorder Society criteria
- Average weekly stool frequency of 5 or fewer spontaneous bowel movements and 2 or fewer complete spontaneous bowel movements over the past 6 months, verified during a 2-week screening period
- Stool consistency of 3 or less on the Bristol Stool Form Scale, verified during a 2-week screening period
- Agreement to use contraception, if applicable
You will not qualify if you...
- Functional diarrhea or irritable bowel syndrome with diarrhea or mixed type based on Rome IV Criteria
- Symptomatic structural gastrointestinal abnormalities or inflammatory bowel disease
- Significant liver dysfunction (ALT or AST 2.5 times or more above normal) or kidney dysfunction (serum creatinine greater than 2 mg/dl)
- Pregnancy or breastfeeding
- Diagnosis of primary dyssynergic defecation confirmed by anorectal manometry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cedar Valley Digestive Health Center
Waterloo, Iowa, United States, 50701
Actively Recruiting
Research Team
R
Richard A. Manfready, MD, AM, FACP
CONTACT
H
Harichandana Punukula, PharmD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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