Lubiprostone as a Treatment for Constipation in Parkinson's Disease

This study has been terminated.

(Lack of recruitment)

Sponsor:

ClinicalTrials.gov Identifier:

NCT00669461

First Posted: April 30, 2008

Last Update Posted: December 30, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Takeda

Information provided by (Responsible Party):

University of Arkansas

Results First Submitted: October 25, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (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
Overall Participants Analyzed [Units: Participants]	1

Age [Units: Participants] Count of Participants
<=18 years	0 0.0%
Between 18 and 65 years	0 0.0%
>=65 years	1 100.0%

Age [Units: Years] Mean (Standard Deviation)	73 (0)

Gender [Units: Participants] Count of Participants
Female	0 0.0%
Male	1 100.0%

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
First Submitted:	April 28, 2008
First Posted:	April 30, 2008
Results First Submitted:	October 25, 2011
Results First Posted:	May 15, 2012
Last Update Posted:	December 30, 2016

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