Lubiprostone as a Treatment for Constipation in Parkinson's Disease

This study has been terminated.

(Lack of recruitment)

Sponsor:

Collaborator:

Takeda

Information provided by (Responsible Party):

University of Arkansas

ClinicalTrials.gov Identifier:

NCT00669461

First received: April 28, 2008

Last updated: April 16, 2012

Last verified: April 2012

History of Changes

Results First Received: October 25, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Constipation Parkinson's Disease
Intervention:	Drug: Lubiprostone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Lubiprostone	patient received treatment( lubiprostone)24 mcg po BID for 4 weeks

Participant Flow: Overall Study

	Lubiprostone
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Lubiprostone	patient received treatment( lubiprostone)24 mcg po BID for 4 weeks

Baseline Measures

	Lubiprostone
Number of Participants [units: participants]	1
Age [units: participants]
<=18 years	0
Between 18 and 65 years	0
>=65 years	1
Age [units: years] Mean (Standard Deviation)	73
Gender [units: participants]
Female	0
Male	1
Region of Enrollment [units: participants]
United States	1

Outcome Measures

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1. Primary:

Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks [ Time Frame: up to 6 weeks ]

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2. Secondary:

Average Number of Spontaneous Bowel Movements (SBM) Per Week [ Time Frame: up to 6 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed

More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Muhannad Heif, MD
Organization: University of Arkansas for Medical Sciences
phone: 5016500215
e-mail: mmheif@gmail.com

Responsible Party:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00669461 History of Changes
Other Study ID Numbers:	78055 FWA00001119
Study First Received:	April 28, 2008
Results First Received:	October 25, 2011
Last Updated:	April 16, 2012
Health Authority:	United States: Institutional Review Board

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