Efficacy of Lubiprostone in Combination With Standard PEG Preparation

This study has been terminated.
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Sherman Chamberlain, Georgia Regents University
ClinicalTrials.gov Identifier:
First received: May 29, 2008
Last updated: October 17, 2014
Last verified: October 2014
Results First Received: September 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Diagnostic
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Interventions: Drug: Lubiprostone
Other: Polyethylene glycol with electrolytes

  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
Study participation was offered to all adult-onset diabetic outpatients 50 and over who were referred to the Gastroenterology clinic at the Medical College of Georgia in Augusta, Georgia for a screening colonoscopy from July, 2008 to March, 2010.

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
Experimental Experimental group received one dose of polyethylene glycol electrolyte (PEG) and one does of lubiprostone two hours prior to and two hours after PED completion on the evening prior to the colonoscopy.
Control Control group received the standard treatment of polyethylene glycol electrolytes the evening prior to the colonoscopy.

Participant Flow:   Overall Study
    Experimental     Control  
STARTED     30     30  
COMPLETED     17     24  
NOT COMPLETED     13     6  
Withdrawal by Subject                 13                 6  

  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
Experimental PEG plus lubiprostone colon cleansing
Control PEG colon cleansing
Total Total of all reporting groups

Baseline Measures
    Experimental     Control     Total  
Number of Participants  
[units: participants]
  30     30     60  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     30     30     60  
>=65 years     0     0     0  
[units: years]
Mean (Standard Deviation)
  55  (7)     62  (8)     58.5  (8)  
[units: participants]
Female     18     17     35  
Male     12     13     25  
Region of Enrollment  
[units: participants]
United States     30     30     60  

  Outcome Measures

1.  Primary:   The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale.   [ Time Frame: The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours ]

  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Sherman M. Chamberlain, Professor of Medicine
Organization: Georgia Regent University
phone: 706-721-2238
e-mail: schamberlain@gru.edu

Publications of Results:

Responsible Party: Sherman Chamberlain, Georgia Regents University
ClinicalTrials.gov Identifier: NCT00689026     History of Changes
Other Study ID Numbers: MCG 08-02-186
Study First Received: May 29, 2008
Results First Received: September 30, 2014
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration