Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Study Overview
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Brief Summary
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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: Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary) Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary) Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)

Official Title
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Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Conditions
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Constipation, Parkinson's Disease

Intervention / Treatment
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* Drug: Lubiprostone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br> | Drug: Lubiprostone<br>* Lubiprostone 24 mcg BID orally for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks | The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone). | up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Number of Spontaneous Bowel Movements (SBM) Per Week | Average number of spontaneous bowel movements (SBM) per week,measured at baseline, at end of 4 weeks of treatment with Lubiprostone and at 2 weeks after stopping Lubiprostone (( so measure was reported at end of week # 1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone)). | up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, Parkinson's Disease