Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:
NCT00399542
First received: November 13, 2006
Last updated: September 25, 2013
Last verified: September 2013
Results First Received: October 7, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Conditions: Irritable Bowel Syndrome
Constipation
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
First subject enrolled 05/19/05; last subject observed 08/02/06, at 65 centers across the US

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were enrolled after an up to 4 week screening period to meet inclusion/exclusion criteria and randomized on Day 0

Reporting Groups
  Description
Lubiprostone Subjects who received active drug
Placebo Subjects who received placebo

Participant Flow:   Overall Study
    Lubiprostone     Placebo  
STARTED     387     194  
COMPLETED     303     151  
NOT COMPLETED     84     43  
Adverse Event                 18                 15  
Protocol Violation                 13                 3  
Withdrawal by Subject                 28                 10  
Lack of Efficacy                 18                 8  
Lost to Follow-up                 6                 6  
Unspecified                 1                 0  
Physician Decision                 0                 1  



  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 Subjects who received active drug
Placebo Subjects who received placebo
Total Total of all reporting groups

Baseline Measures
    Lubiprostone     Placebo     Total  
Number of Participants  
[units: participants]
  379     192     571  
Age  
[units: years]
Mean ± Standard Deviation
  45.5  ± 12.93     47.3  ± 13.34     46.1  ± 13.08  
Gender  
[units: participants]
     
Female     343     179     522  
Male     36     13     49  
Height  
[units: inches]
Mean ± Standard Deviation
  64.7  ± 3.15     65.0  ± 3.34     64.8  ± 3.21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Responder Status   [ Time Frame: 12 weeks ]

2.  Secondary:   Month 1 Spontaneous Bowel Movement Rates Change From Baseline   [ Time Frame: 28 days ]

3.  Secondary:   Month 1 Stool Consistency Change From Baseline   [ Time Frame: 28 days ]

4.  Secondary:   Month 1 Bowel Straining Change From Baseline   [ Time Frame: 28 days ]

5.  Secondary:   Month 1 Constipation Severity Change From Baseline   [ Time Frame: 28 days ]

6.  Secondary:   Month 1 Symptom Relief   [ Time Frame: 28 days ]

7.  Secondary:   Month 1 Responder Rate   [ Time Frame: 28 days ]

8.  Secondary:   Month 2 Responder Rate   [ Time Frame: 28 days ]

9.  Secondary:   Month 3 Responder Rate   [ Time Frame: 28 days ]

10.  Secondary:   Month 1 Abdominal Pain Change From Baseline   [ Time Frame: 28 days ]

11.  Secondary:   Month 2 Abdominal Pain Change From Baseline   [ Time Frame: 28 days ]

12.  Secondary:   Month 3 Abdominal Pain Change From Baseline   [ Time Frame: 28 days ]

13.  Secondary:   Month 1 Abdominal Bloating Change From Baseline   [ Time Frame: 28 days ]

14.  Secondary:   Month 2 Abdominal Bloating Change From Baseline   [ Time Frame: 28 days ]

15.  Secondary:   Month 3 Abdominal Bloating Change From Baseline   [ Time Frame: 28 days ]

16.  Secondary:   Month 2 Spontaneous Bowel Movement Rates Change From Baseline   [ Time Frame: 28 days ]

17.  Secondary:   Month 3 Spontaneous Bowel Movement Rates Change From Baseline   [ Time Frame: 28 days ]

18.  Secondary:   Month 2 Stool Consistency Change From Baseline   [ Time Frame: 28 days ]

19.  Secondary:   Month 3 Stool Consistency Change From Baseline   [ Time Frame: 28 days ]

20.  Secondary:   Month 2 Bowel Straining Change From Baseline   [ Time Frame: 28 days ]

21.  Secondary:   Month 3 Bowel Straining Change From Baseline   [ Time Frame: 28 days ]

22.  Secondary:   Month 2 Constipation Severity Change From Baseline   [ Time Frame: 28 days ]

23.  Secondary:   Month 3 Constipation Severity Change From Baseline   [ Time Frame: 28 days ]

24.  Secondary:   Month 2 Symptom Relief   [ Time Frame: 28 days ]

25.  Secondary:   Month 3 Symptom Relief   [ Time Frame: 28 days ]

26.  Secondary:   Month 3 Quality of Life Change From Baseline   [ Time Frame: 12 weeks ]

27.  Secondary:   Month 1 Bowel Movement Rates Change From Baseline   [ Time Frame: 28 days ]

28.  Secondary:   Month 2 Bowel Movement Rates Change From Baseline   [ Time Frame: 28 days ]

29.  Secondary:   Month 3 Bowel Movement Rates Change From Baseline   [ Time Frame: 28 days ]


  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: Raymond Panas, PhD
Organization: Sucampo Pharmaceuticals, Inc.
phone: 301-961-3400
e-mail: info@sucampo.com


No publications provided


Responsible Party: Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT00399542     History of Changes
Other Study ID Numbers: 0211SIB-0432
Study First Received: November 13, 2006
Results First Received: October 7, 2008
Last Updated: September 25, 2013
Health Authority: United States: Food and Drug Administration