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Trial of Linaclotide in Patients With Chronic Constipation

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00730015
First received: August 5, 2008
Last updated: December 19, 2012
Last verified: December 2012
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: Chronic Constipation
Interventions: Drug: Matching Placebo
Drug: Linaclotide

  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 from August 2008 to August 2009 at 109 U.S. study centers.

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).

Reporting Groups
  Description
Linaclotide, 145μg Linaclotide, 145μg dose, oral administration, once per day
Linaclotide, 290μg Linaclotide, 290μg dose, oral administration, once per day
Placebo Dose matched placebo, oral administration, once per day

Participant Flow:   Overall Study
    Linaclotide, 145μg   Linaclotide, 290μg   Placebo
STARTED   217   217   209 
COMPLETED   186   177   177 
NOT COMPLETED   31   40   32 
Adverse Event                11                10                8 
Protocol Violation                2                6                4 
Withdrawal by Subject                12                12                8 
Lost to Follow-up                4                10                3 
Lack of Efficacy                1                2                8 
Other Reason                1                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
Linaclotide, 145μg Linaclotide, 145μg dose, oral administration, once per day
Linaclotide, 290μg Linaclotide, 290μg dose, oral administration, once per day
Placebo Dose matched placebo, oral administration, once per day
Total Total of all reporting groups

Baseline Measures
   Linaclotide, 145μg   Linaclotide, 290μg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 217   217   209   643 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.1  (14.2)   47.7  (14.2)   49.3  (14.3)   48.0  (14.3) 
Age, Customized 
[Units: Participants]
       
18 years to 64 years   190   190   181   561 
65 years and older   27   27   28   82 
Gender 
[Units: Participants]
       
Female   191   189   182   562 
Male   26   28   27   81 
Region of Enrollment 
[Units: Participants]
       
United States   217   217   209   643 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Spontaneous Bowel Movement (CSBM) Overall Responder   [ Time Frame: Change from Baseline to Week 12 ]

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

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

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

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

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

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

8.  Secondary:   12-week Change in Constipation Severity   [ 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: NCT00730015     History of Changes
Other Study ID Numbers: MCP-103-303
Study First Received: August 5, 2008
Results First Received: September 28, 2012
Last Updated: December 19, 2012