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Effect of Lubiprostone on Small Bowel Contractions in Female Patients With Constipation Irritable Bowel Syndrome (C-IBS)

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Edy E Soffer, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01085643
First received: March 11, 2010
Last updated: November 8, 2011
Last verified: November 2011
Results First Received: June 22, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Basic Science
Condition: Constipation-predominant Irritable Bowel Syndrome
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
Recruitment dates: March 2010 to December 2010 Recruitment place: GI Motility Clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects will have to stop medications affecting small bowel motility 7 days prior to the procedure. Risks expected in this washout period include recurrence of constipation predominant Irritable Bowel Syndrome symptoms- abdominal pain, bloating and constipation. Subjects will be instructed to call the study staff if symptom recurrence occurs.

Reporting Groups
  Description
Placebo Then Lubiprostone Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.

Participant Flow:   Overall Study
    Placebo Then Lubiprostone  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     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
Placebo Then Lubiprostone Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.

Baseline Measures
    Placebo Then Lubiprostone  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 1  
Gender  
[units: participants]
 
Female     4  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
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1.  Primary:   A Change in Length of Spread of Antegrade Contractions After Placebo.   [ Time Frame: baseline and within the following 3 hours ]

2.  Primary:   A Change in Length of Spread of Antegrade Contractions After Lubiprostone   [ Time Frame: baseline and within the following 3 hours ]

3.  Secondary:   A Change in Length of Spread of Long Distance Propagating Contractions After Placebo.   [ Time Frame: baseline and within the following 3 hours ]

4.  Secondary:   A Change in Length of Spread of Retrograde Contractions After Placebo   [ Time Frame: baseline and within the following 3 hours ]

5.  Secondary:   A Change in Length of Spread of Long Distance Propagating Contractions After Lubiprostone   [ Time Frame: baseline and within the following 3 hours ]

6.  Secondary:   A Change in Length of Spread of Retrograde Contractions After Lubiprostone   [ Time Frame: baseline and within the following 3 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
Limited time period resulting in recruitment of only 4 patients.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Edy Soffer, MD
Organization: Cedars-Sinai Medical Center
phone: (310) 423-6143
e-mail: edy.soffer@cshs.org


No publications provided


Responsible Party: Edy E Soffer, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01085643     History of Changes
Other Study ID Numbers: 17482
Study First Received: March 11, 2010
Results First Received: June 22, 2011
Last Updated: November 8, 2011
Health Authority: United States: Institutional Review Board