Status:
TERMINATED
Lubiprostone as a Treatment for Constipation in Parkinson's Disease
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
Takeda
Conditions:
Constipation
Parkinson's Disease
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic tr...
Eligibility Criteria
Inclusion
- Age 50-85 years
- Diagnosis of Parkinson's disease
- Constipation as defined by the Rome III committee
- BSFS of more or equal to 1 and less or equal to 3
- Normal colonoscopy in the last 5 years( normal defined as absence of obstructive lesions in the colon)
- All women subjects will be post menopausal or surgically sterile.
Exclusion
- Known hypersensitivity reaction to Amitiza ( Lubiprostone)
- Known significant adverse effects to previous treatment with Lubiprostone which include; new or worsening abdominal pain, severe diarrhea, nausea, vomiting, and severe headache.
- Renal dysfunction with creatinine clearance less than 15 ml/min
- Abnormal liver enzymes or history of chronic liver disorder
- History of bowel obstruction, , or abdominal adhesions .
- Abnormal Colonoscopy ( obstructive lesions within the colon)
- Inability to give informed consent
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00669461
Start Date
June 1 2009
End Date
September 1 2010
Last Update
December 30 2016
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205