Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00460811
First received: April 13, 2007
Last updated: January 29, 2013
Last verified: January 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
Interventions: Drug: Linaclotide Acetate
Drug: 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 12 month period from March 2007 to February 2008 at 92 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 17 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
72 μg Linaclotide Acetate Linaclotide, 72μg dose, oral administration, once per day
145 μg Linaclotide Acetate Linaclotide, 145μg dose, oral administration, once per day
290 μg Linaclotide Acetate Linaclotide, 290μg dose, oral administration, once per day
579 μg Linaclotide Acetate Linaclotide, 579μg dose, oral administration, once per day
Matching Placebo Dose-matched placebo, oral administration, once per day

Participant Flow:   Overall Study
    72 μg Linaclotide Acetate     145 μg Linaclotide Acetate     290 μg Linaclotide Acetate     579 μg Linaclotide Acetate     Matching Placebo  
STARTED     79     82     85     89     85  
COMPLETED     63     67     71     71     65  
NOT COMPLETED     16     15     14     18     20  
Adverse Event                 4                 6                 3                 10                 2  
Noncompliance                 1                 0                 0                 2                 1  
Withdrawal by Subject                 7                 7                 6                 3                 11  
Physician Decision                 1                 0                 0                 0                 0  
Lost to Follow-up                 3                 2                 5                 3                 6  



  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
72 µg Linaclotide Acetate Linaclotide, 72μg dose, oral administration, once per day
145 µg Linaclotide Acetate Linaclotide, 145μg dose, oral administration, once per day
290 µg Linaclotide Acetate Linaclotide, 290μg dose, oral administration, once per day
579 µg Linaclotide Acetate Linaclotide, 579μg dose, oral administration, once per day
Matching Placebo Dose-matched placebo, oral administration, once per day
Total Total of all reporting groups

Baseline Measures
    72 µg Linaclotide Acetate     145 µg Linaclotide Acetate     290 µg Linaclotide Acetate     579 µg Linaclotide Acetate     Matching Placebo     Total  
Number of Participants  
[units: participants]
  79     82     85     89     85     420  
Age  
[units: years]
Mean ± Standard Deviation
  42.3  ± 12.5     45.6  ± 10.8     45.8  ± 11.4     43.7  ± 11.4     44.3  ± 11.3     44.4  ± 11.5  
Age, Customized  
[units: Participants]
           
18 years to 65 years     77     79     81     86     85     408  
Older than 65 years     2     3     4     3     0     12  
Gender  
[units: participants]
           
Female     74     78     78     79     78     387  
Male     5     4     7     10     7     33  
Region of Enrollment  
[units: participants]
           
United States     75     79     80     86     81     401  
Canada     4     3     5     3     4     19  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period   [ Time Frame: Change from Baseline to Week 12 ]

2.  Secondary:   CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)   [ Time Frame: Change from Baseline to Week 12 ]

3.  Secondary:   Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period   [ Time Frame: Change from Baseline to Week 12 ]

4.  Secondary:   Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period   [ Time Frame: Change from Baseline to Week 12 ]

5.  Secondary:   Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period   [ Time Frame: Change from Baseline to Week 12 ]

6.  Secondary:   Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period   [ Time Frame: Change from Baseline to Week 12 ]

7.  Secondary:   Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period   [ 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


No publications provided by Ironwood Pharmaceuticals, Inc.

Publications automatically indexed to this study:

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00460811     History of Changes
Other Study ID Numbers: MCP-103-202
Study First Received: April 13, 2007
Results First Received: September 28, 2012
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration