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Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00746395
First Posted: September 4, 2008
Last Update Posted: January 4, 2017
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.
Collaborators:
Takeda
Sucampo Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jack DiPalma, University of South Alabama
Results First Submitted: August 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Diagnostic
Condition: Inflammatory Bowel Disease
Interventions: Drug: Lubiprostone
Drug: Placebo

  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 a speciality clinic in Mobile, AL, USA between October 2007 and August 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
45 participants recruited and screened, 1 excluded, 4 withdrew from study.

Reporting Groups
  Description
Lubiprostone 24mcg Single Dose lubiprostone 24mcg single dose po prior to capsule endoscopy
Sugar Pill Placebo (sugar pill) - matched single dose po prior to capsule endoscopy

Participant Flow:   Overall Study
    Lubiprostone 24mcg Single Dose   Sugar Pill
STARTED   20   20 
COMPLETED   20   20 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
Lubiprostone 24mcg Single Dose lubiprostone 24mcg single dose po prior to capsule endoscopy
Sugar Pill Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
Total Total of all reporting groups

Baseline Measures
   Lubiprostone 24mcg Single Dose   Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      20 100.0%      20 100.0%      40 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.75  (13.15045)   35.4  (10.86472)   37.07  (2.36881) 
Gender 
[Units: Participants]
Count of Participants
     
Female      15  75.0%      12  60.0%      27  67.5% 
Male      5  25.0%      8  40.0%      13  32.5% 
Region of Enrollment 
[Units: Participants]
     
United States   20   20   40 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Small Bowel Transit   [ Time Frame: 8 hours ]

2.  Secondary:   Small Bowel Transit   [ Time Frame: Duration of the test - 8 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
Study participant enrollment met per protocol requirement.


  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: Jack A. DiPalma, M.D.
Organization: University of South Alabama
phone: 251-660-5555
e-mail: jdipalma@usouthal.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jack DiPalma, University of South Alabama
ClinicalTrials.gov Identifier: NCT00746395     History of Changes
Other Study ID Numbers: 07-096
First Submitted: September 3, 2008
First Posted: September 4, 2008
Results First Submitted: August 15, 2013
Results First Posted: January 4, 2017
Last Update Posted: January 4, 2017