Efficacy of Lubiprostone in Combination With Standard PEG Preparation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00689026
Recruitment Status : Terminated
First Posted : June 3, 2008
Results First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Sherman Chamberlain, Augusta University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Diagnostic
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Interventions: Drug: Lubiprostone
Other: Polyethylene glycol with electrolytes

  Participant Flow

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
No text entered.

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 
Withdrawal by Subject                13                6 

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

Baseline Measures
   Experimental   Control   Total 
Overall Participants Analyzed 
[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

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

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

Publications of Results:

Responsible Party: Sherman Chamberlain, Augusta University Identifier: NCT00689026     History of Changes
Other Study ID Numbers: MCG 08-02-186
First Submitted: May 29, 2008
First Posted: June 3, 2008
Results First Submitted: September 30, 2014
Results First Posted: October 20, 2014
Last Update Posted: October 20, 2014