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
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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
  Show All Outcome Measures

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 ]

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


  Serious Adverse Events


  Other Adverse Events


  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


No publications provided


Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00669461     History of Changes
Other Study ID Numbers: 78055, 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