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Amitiza in Constipation Associated With PD (Parkinson's Disease) (AMITIZA)

This study has been completed.
Sponsor:
Collaborator:
University of South Florida
Information provided by (Responsible Party):
Christine Hunter, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00908076
First received: May 21, 2009
Last updated: July 18, 2016
Last verified: July 2016
Results First Received: February 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: 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
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Reporting Groups
  Description
Amitiza LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
Placebo LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.

Participant Flow:   Overall Study
    Amitiza   Placebo
STARTED   27   27 
COMPLETED   26   26 
NOT COMPLETED   1   1 
Lack of Efficacy                1                1 



  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.
Patients were included if they had PD using standard criteria, were aged 35 to 85 years, and met the ROME II criteria19 and scored at least 10 on the ROME II constipation assessment. Excluded if they had any other identifiable cause of constipation, use of opioids, anticholinergic agents, or antacids containing magnesium or aluminum salts.

Reporting Groups
  Description
Amitiza LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
Placebo LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
Total Total of all reporting groups

Baseline Measures
   Amitiza   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   27   54 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.3  (8.1)   70.1  (12.2)   68.0  (10.15) 
Gender 
[Units: Participants]
     
Female   7   8   15 
Male   20   19   39 
Region of Enrollment 
[Units: Participants]
     
United States   27   27   54 
PD duration 
[Units: Years]
Mean (Standard Deviation)
 8.9  (6.3)   9.5  (6.3)   9.2  (6.3) 


  Outcome Measures

1.  Primary:   Change From Baseline to End of Study   [ Time Frame: Baseline to end of study ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christine Hunter
Organization: Baylor College of Medicine
phone: 713-798-6556
e-mail: chunter@bcm.edu


Publications:

Responsible Party: Christine Hunter, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00908076     History of Changes
Obsolete Identifiers: NCT00849784
Other Study ID Numbers: H-21192
Study First Received: May 21, 2009
Results First Received: February 12, 2016
Last Updated: July 18, 2016
Health Authority: United States: Institutional Review Board