Lubiprostone as a Treatment for Constipation in Parkinson's Disease - Full Text View

Sponsors and Collaborators:	University of Arkansas Takeda Global Research & Development Center, Inc.
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00669461

Purpose

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)

Condition	Intervention
Constipation Parkinson's Disease	Drug: Lubiprostone

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Constipation Parkinson's Disease

Drug Information available for: Lubiprostone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Crossover Assignment
Official Title:	Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline. [ Time Frame: Daily for 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. [ Time Frame: daily for 6 weeks ] [ Designated as safety issue: No ]
Lubiprostone will improve health related quality of life in subjects with PD induced constipation. [ Time Frame: daily for 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Patients: Experimental	Drug: Lubiprostone Lubiprostone 24 mcg BID orally for 4 weeks

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669461

Contacts

Contact: Muhannad M Heif, M.D		mmheif@uams.edu
Contact: Jomana T. Al-Hinti, MD		alhintijomanat@uams.edu

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

Takeda Global Research & Development Center, Inc.

Investigators

Principal Investigator:

Kevin W Olden, MD

University of Arkansas

More Information

Responsible Party:	University of Arkansas for Medical Sciences ( Kevin W. Olden, MD )
Study ID Numbers:	78055, 78055, FWA00001119
Study First Received:	April 28, 2008
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00669461
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

Constipation
Parkinson's Disease

Study placed in the following topic categories:

Signs and Symptoms
Ganglion Cysts
Signs and Symptoms, Digestive
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Constipation
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009