Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Not Applicable

Terminated

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 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)

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Patients	Lubiprostone	-

Primary Outcome Measures

Name	Time	Method
Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks	up to 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).

Secondary Outcome Measures

Name	Time	Method
Average Number of Spontaneous Bowel Movements (SBM) Per Week	up to 6 weeks	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)).