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: October 9, 2013
Last verified: October 2013
Results First Received: September 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   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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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.
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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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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

2.  Primary:   Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks   [ Time Frame: Change from Baseline to Week 12 ]

3.  Primary:   Abdominal Pain Responder, 9 Out of 12 Weeks   [ Time Frame: Change from Baseline to Week 12 ]

4.  Primary:   Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks   [ Time Frame: Change from Baseline to Week 12 ]

5.  Secondary:   12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency   [ Time Frame: Change from Baseline to Week 12 ]

6.  Secondary:   12-Week Spontaneous Bowl Movement (SBM) Frequency   [ Time Frame: Change from Baseline to Week 12 ]

7.  Secondary:   12-Week Change in Stool Consistency   [ Time Frame: Change from Baseline to Week 12 ]

8.  Secondary:   12-Week Change in Severity of Straining   [ Time Frame: Change from Baseline to Week 12 ]

9.  Secondary:   12-Week Change in Abdominal Pain Score   [ Time Frame: Change from Baseline to Week 12 ]

10.  Secondary:   12-Week Change in Abdominal Discomfort   [ Time Frame: Change from Baseline to Week 12 ]

11.  Secondary:   12-Week Change in Bloating   [ Time Frame: Change from Baseline to Week 12 ]

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 ]

13.  Secondary:   Abdominal Pain Responder for 6 Out of 12 Weeks   [ Time Frame: Change from Baseline to Week 12 ]

14.  Secondary:   12-Week Percent of Abdominal Pain-free Days   [ Time Frame: Change from Baseline to Week 12 ]


  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 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.


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


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

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: October 9, 2013