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| Sponsor: | Baylor College of Medicine |
|---|---|
| Collaborator: |
University of South Florida |
| Information provided by: | Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00908076 |
Purpose
The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe and effective for chronic constipation, will also improve constipation symptoms in Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in bowel movement consistency, quality of life and motor symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: LUBIPROSTONE |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF LUBIPROSTONE IN THE TREATMENT OF CONSTIPATION ASSOCIATED WITH PARKINSON'S DISEASE. |
| Estimated Enrollment: | 78 |
| Study Start Date: | February 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: amitiza |
Drug: LUBIPROSTONE
Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
|
| Placebo Comparator: Placebo |
Drug: LUBIPROSTONE
Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
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Parkinson's disease (PD) affects about one million people in the United States. It is a common neurological condition that is clinically defined by rigidity (muscle stiffness), bradykinesia (slowness of movement) and tremor. Parkinson's Disease , however, reveals numerous non-motor symptoms that have been underemphasized. Problematic symptoms include varying degrees of dementia, psychosis, diminished assertiveness and confidence, general fatigue, excessive daytime sleepiness, problems with blood pressure, sweating, and bladder, and a common yet difficult to define sense of "not feeling well".
A commonly missed symptom in Parkinson's patients is constipation. Constipation can be difficult to treat with current medications available and many are ineffective. Levodopa and dopamine agonists drugs are useful for motor symptoms in Parkinson's Disease but have no effect on constipation. Laxatives and enemas provide limited relief with bothersome side effects. Even fewer drugs have been studied targeting the constipation problem specifically in the Parkinson's Disease population. Lubiprostone (AMITIZA) is a new medication that has been studied in the general population for the treatment of chronic constipation. It has been shown to be a safe and effective medication with few side effects. Lubiprostone has not yet been studied in the Parkinson's Disease population. We hope to show that this medication can be safe and effective for constipation in PD patients as well.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| University of South Florida | |
| Tampa, Florida, United States, 33606 | |
| United States, Texas | |
| Baylor College of Medicine PDCMDC | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | William G Ondo, MD | Baylor College of Medicine |
More Information
| Responsible Party: | William G. Ondo, MD, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00908076 History of Changes |
| Other Study ID Numbers: | H21192 |
| Study First Received: | May 21, 2009 |
| Last Updated: | April 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
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constipation Parkinson's disease |
|
Constipation Parkinson Disease Signs and Symptoms, Digestive Signs and Symptoms Parkinsonian Disorders Basal Ganglia Diseases |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |