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Lubiprostone as a Treatment for Constipation in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00669461
Recruitment Status : Terminated (Lack of recruitment)
First Posted : April 30, 2008
Results First Posted : May 15, 2012
Last Update Posted : December 30, 2016
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
University of Arkansas

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

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

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 
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

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 ]
  Show Outcome Measure 1

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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