Trial of Linaclotide in Patients With Chronic Constipation
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|ClinicalTrials.gov Identifier: NCT00730015|
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : January 30, 2013
Last Update Posted : January 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Constipation||Drug: Matching Placebo Drug: Linaclotide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||643 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Chronic Constipation|
|Study Start Date :||August 2008|
|Primary Completion Date :||August 2009|
|Study Completion Date :||October 2009|
|Experimental: 145 μg linaclotide||
Oral, once daily
|Experimental: 290 μg linaclotide||
Oral, once daily
|Placebo Comparator: Matching Placebo||
Drug: Matching Placebo
Oral, once daily
- Complete Spontaneous Bowel Movement (CSBM) Overall Responder [ Time Frame: Change from Baseline to Week 12 ]
A 12-week CSBM Overall Responder was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.
An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
- 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency [ Time Frame: Change from Baseline to Week 12 ]The number of CSBMs per week.
- 12-Week Spontaneous Bowl Movement (SBM) Frequency [ Time Frame: Change from Baseline to Week 12 ]The number of SBMs per week.
- 12-week Change in Stool Consistency [ Time Frame: Change from Baseline to Week 12 ]
The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:
- = separate hard lumps like nuts [difficult to pass]
- = sausage shaped but lumpy
- = like a sausage but with cracks on surface
- = like a sausage or snake, smooth and soft
- = soft blobs with clear-cut edges [passed easily]
- = fluffy pieces with ragged edges, a mushy stool
- = watery, no solid pieces [entirely liquid]
- 12-week Change in Severity of Straining [ Time Frame: Change from Baseline to Week 12 ]Severity of Straining is measured on a 5-point scale, where a value of 1 is "not at all" and a value of 5 is "an extreme amount".
- 12-week Change in Abdominal Discomfort [ Time Frame: Change from Baseline to Week 12 ]Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."
- 12-week Change in Bloating [ Time Frame: Change from Baseline to Week 12 ]Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".
- 12-week Change in Constipation Severity [ Time Frame: Change from Baseline to Week 12 ]Constipation severity was based on a 5-point ordinal scale where a value of l is "none" and a value of 5 is "very severe".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730015
Show 105 Study Locations
|Study Chair:||Jeffrey M. Johnston, MD, FACP||Ironwood Pharmaceuticals, Inc.|