Trials / Terminated
TerminatedNCT00669461
Lubiprostone as a Treatment for Constipation in Parkinson's Disease
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- University of Arkansas · Academic / Other
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
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 transit time in healthy volunteers in addition to activating the chloride channels in the intestinal cells, it has the potential to improve constipation in patients with PD with no subsequent adverse events on the control of the neurological manifestation of PD. So we hypothesize the following: 1. Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary) 2. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary) 3. Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lubiprostone | Lubiprostone 24 mcg BID orally for 4 weeks |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2010-09-01
- Completion
- 2010-09-01
- First posted
- 2008-04-30
- Last updated
- 2016-12-30
- Results posted
- 2012-05-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00669461. Inclusion in this directory is not an endorsement.