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Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

This study has been completed.
Sponsor:
Collaborator:
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00765882
First received: October 1, 2008
Last updated: December 19, 2012
Last verified: December 2012
Results First Received: September 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Constipation
Interventions: Drug: Linaclotide 290 micrograms
Drug: Linaclotide 145 micrograms
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
Patient Recruitment occurred from October 2008 to March 2009 at 103 study centers (95 in the United States and 8 in Canada).

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
Placebo Dose matched placebo, oral administration, once per day.
Linaclotide 145µg Linaclotide, 145µg dose, oral administration, once per day
Linaclotide 290µg Linaclotide, 290µg dose, oral administration, once per day

Participant Flow:   Overall Study
    Placebo     Linaclotide 145µg     Linaclotide 290µg  
STARTED     215     213     205  
COMPLETED     191     173     169  
NOT COMPLETED     24     40     36  
Adverse Event                 10                 21                 20  
Lack of Efficacy                 4                 0                 1  
Protocol Violation                 4                 3                 1  
Withdrawal by Subject                 2                 6                 6  
Lost to Follow-up                 1                 9                 6  
Other Reason                 3                 1                 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.
No text entered.

Reporting Groups
  Description
Placebo Dose matched placebo, oral administration, once per day.
Linaclotide 145µg Linaclotide, 145µg dose, oral administration, once per day
Linaclotide 290µg Linaclotide, 290µg dose, oral administration, once per day
Total Total of all reporting groups

Baseline Measures
    Placebo     Linaclotide 145µg     Linaclotide 290µg     Total  
Number of Participants  
[units: participants]
  215     213     205     633  
Age  
[units: years]
Mean ± Standard Deviation
  47.0  ± 13.5     48.5  ± 12.3     47.3  ± 13.3     47.6  ± 13.0  
Age, Customized  
[units: participants]
       
18 years to 64 years     188     189     183     560  
65 years and older     27     24     22     73  
Gender  
[units: participants]
       
Female     196     195     181     572  
Male     19     18     24     61  
Region of Enrollment  
[units: participants]
       
United States     208     208     198     614  
Canada     7     5     7     19  



  Outcome Measures
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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 Rate   [ Time Frame: Change from Baseline to Week 12 ]

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

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

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

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

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

8.  Secondary:   12-Week 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: Paul F.C. Eng, PhD. Director, Clinical Development
Organization: Forest Research Institute
phone: 201-427-8071
e-mail: Paul.Eng@frx.com


No publications provided by Forest Laboratories

Publications automatically indexed to this study:

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00765882     History of Changes
Other Study ID Numbers: LIN-MD-01
Study First Received: October 1, 2008
Results First Received: September 28, 2012
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada