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Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00938717
First received: July 12, 2009
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
Results First Received: September 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Irritable Bowel Syndrome With Constipation
Intervention: Drug: Linaclotide or Matching 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
Patient recruitment occurred over a fifteen month period from July 2009 to September 2010 at 111 US study sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients went through a 14 to 21 day Pretreatment Period during which the patients provided qualifying bowel habit and symptoms, and rescue medicine usage information through an interactive voice response system (IVRS). All randomized patients needed an abdominal pain score ≥ 3.

Reporting Groups
  Description
Placebo Dose-matched placebo, oral administration, once per day.
Linaclotide Linaclotide 290μg, oral administration, once per day.

Participant Flow:   Overall Study
    Placebo     Linaclotide  
STARTED     403     402  
COMPLETED     305     294  
NOT COMPLETED     98     108  
Adverse Event                 10                 41  
Protocol Violation                 11                 8  
Withdrawal by Subject                 26                 24  
Lost to Follow-up                 13                 18  
Lack of Efficacy                 33                 15  
Other reason                 5                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Dose-matched placebo, oral administration, once per day.
Linaclotide Linaclotide 290μg, oral administration, once per day.
Total Total of all reporting groups

Baseline Measures
    Placebo     Linaclotide     Total  
Number of Participants  
[units: participants]
 		  403     402     805  
Age  
[units: years]
Mean ± Standard Deviation 		  44.0  ± 13.4     44.7  ± 13.1     44.3  ± 13.3  
Age, Customized  
[units: Participants]
 		     
18 years 64 years     386     379     765  
65 years and older     17     23     40  
Gender  
[units: participants]
 		     
Female     352     369     721  
Male     51     33     84  
Region of Enrollment  
[units: participants]
 		     
United States     403     402     805  



  Outcome Measures
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1.  Primary:   Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks   [ Time Frame: Change from Baseline to Week 12 ]
  Show Outcome Measure 1

2.  Primary:   Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks   [ Time Frame: Change from Baseline to Week 12 ]
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3.  Primary:   Abdominal Pain Responder, 9 Out of 12 Weeks   [ Time Frame: Change from Baseline to Week 12 ]
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4.  Primary:   Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks   [ Time Frame: Change from Baseline to Week 12 ]
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5.  Secondary:   12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency   [ Time Frame: Change from Baseline to Week 12 ]
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6.  Secondary:   12-Week Spontaneous Bowl Movement (SBM) Frequency   [ Time Frame: Change from Baseline to Week 12 ]
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7.  Secondary:   12-Week Change in Stool Consistency   [ Time Frame: Change from Baseline to Week 12 ]
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8.  Secondary:   12-Week Change in Severity of Straining   [ Time Frame: Change from Baseline to Week 12 ]
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9.  Secondary:   12-Week Change in Abdominal Pain Score   [ Time Frame: Change from Baseline to Week 12 ]
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10.  Secondary:   12-Week Change in Abdominal Discomfort   [ Time Frame: Change from Baseline to Week 12 ]
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11.  Secondary:   12-Week Change in Bloating   [ Time Frame: Change from Baseline to Week 12 ]
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12.  Secondary:   Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment   [ Time Frame: Change from Baseline to Week 12 ]
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13.  Secondary:   Abdominal Pain Responder for 6 Out of 12 Weeks   [ Time Frame: Change from Baseline to Week 12 ]
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14.  Secondary:   12-Week Percent of Abdominal Pain-free Days   [ Time Frame: Change from Baseline to Week 12 ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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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 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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: Doug Levine, MD
Organization: Ironwood Pharmaceuticals
phone: 617.374.3906
e-mail: dlevine@ironwoodpharma.com


No publications provided by Ironwood Pharmaceuticals, Inc.

Publications automatically indexed to this study:


Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00938717     History of Changes
Other Study ID Numbers: MCP-103-302
Study First Received: July 12, 2009
Results First Received: September 28, 2012
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration