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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
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: 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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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  
Number of Participants  
[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
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1.  Primary:   Complete Spontaneous Bowel Movement (CSBM) Overall Responder   [ Time Frame: Change from Baseline to Week 12 ]
  Show Outcome Measure 1

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

3.  Secondary:   12-Week Spontaneous Bowl Movement (SBM) Frequency   [ Time Frame: Change from Baseline to Week 12 ]
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4.  Secondary:   12-week Change in Stool Consistency   [ Time Frame: Change from Baseline to Week 12 ]
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5.  Secondary:   12-week Change in Severity of Straining   [ Time Frame: Change from Baseline to Week 12 ]
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6.  Secondary:   12-week Change in Abdominal Discomfort   [ Time Frame: Change from Baseline to Week 12 ]
  Show Outcome Measure 6

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

8.  Secondary:   12-week Change in Constipation Severity   [ Time Frame: Change from Baseline to Week 12 ]
  Show Outcome Measure 8


  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: 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
Health Authority: United States: Food and Drug Administration