drugset / Trial / NCT00669461

Lubiprostone as a Treatment for Constipation in Parkinson's Disease

NCT00669461

Non-randomizedCrossoverOpen-labelTreatment

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)

Timeline

Start
2009-06
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Lubiprostone Small molecule 24 ug Oral