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Lubiprostone Effect on Gastrointestinal (GI) Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier:
NCT01469819
First received: October 28, 2011
Last updated: June 17, 2016
Last verified: June 2016
Results First Received: May 9, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Idiopathic Constipation
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
Participants recruited from University of Kansas Medical Center, in Kansas City, KS from July 2008 to August 2009. Additional participants were recruited from Texas Tech University Health Sciences Center - El Paso, in El Paso, TX between April 2012 and November 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
37 participants recruited; 37 screened, 8 excluded. 25 of those subjects participated in small intestinal bacterial overgrowth (SIBO) testing and analysis.

Reporting Groups
  Description
All Participants Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.

Participant Flow:   Overall Study
    All Participants
STARTED   37 
COMPLETED   29 
NOT COMPLETED   8 
Withdrawal by Subject                1 
Did not meet inclusionary criteria                2 
Could not swallow SmartPill                2 
Technical malfunction of SmartPill data                3 



  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
All Participants Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   29 
>=65 years   0 
Age 
[Units: Years]
Mean (Full Range)
 39 
 (19 to 64) 
Gender 
[Units: Participants]
 
Female   29 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   29 


  Outcome Measures
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1.  Primary:   Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day.   [ Time Frame: Measured at baseline and 2 weeks after baseline. ]

2.  Secondary:   Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID).   [ Time Frame: Measured at baseline and 2 weeks after baseline ]

3.  Secondary:   Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients.   [ Time Frame: Measured at baseline and 2 weeks after baseline. ]

4.  Secondary:   Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG Transit Times Measured by SmartPill in Chronically Constipated Patients Treated for 2 Weeks With Lubiprostone 24mcg Twice a Day.   [ Time Frame: Measured at baseline and 2 weeks after baseline. ]

5.  Secondary:   Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks.   [ Time Frame: Measured at baseline and 2 weeks after baseline. ]


  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: Dr. Irene Sarosiek
Organization: Texas Tech University Health Sciences Center El Paso
phone: (915)215-5254
e-mail: irene.sarosiek@ttuhsc.edu



Responsible Party: Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT01469819     History of Changes
Other Study ID Numbers: LUB-119
Study First Received: October 28, 2011
Results First Received: May 9, 2016
Last Updated: June 17, 2016
Health Authority: United States: Institutional Review Board