DRUG
Matching Placebo
Oral, once daily
Trial of Linaclotide in Patients With Chronic Constipation
Status
Completed
Phase
Phase 3
Enrollment
643
Locations
105
Results
Posted
Publications
2
Study summary
What the protocol is testing.
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.
Interventions
Treatment arms and agents.
DRUG
Linaclotide
Oral, once daily
Timeline
From registration to results.
First posted
Aug 8, 2008
Study start
Aug 2008
Primary completion
Aug 2009
Study completion
Oct 2009
Results posted
Jan 30, 2013
Registry updated
Jan 30, 2013
Outcomes
What the study measures.
Primary outcomes
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.
Secondary outcomes
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: 1. = separate hard lumps like nuts \[difficult to pass\] 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges \[passed easily\] 6. = fluffy pieces with ragged edges, a mushy stool 7. = 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".
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings * Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests * Patient meets protocol criteria for CC: reports \< 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs * Patient demonstrates continued chronic constipation through Pretreatment Period * Patient is compliant with IVRS Exclusion Criteria: * Patient has history of loose or watery stools * Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS) * Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility * Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
Study locations
105 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Ironwood Investigational Site
Birmingham, Alabama, United States
Ironwood Investigational Site
Huntsville, Alabama, United States
Ironwood Investigational Site
Chandler, Arizona, United States
Ironwood Investigational Site
Phoenix, Arizona, United States
Ironwood Investigational Site
Tucson, Arizona, United States
Ironwood Investigational Site
Tuscon, Arizona, United States
Ironwood Investigational Site
Sherwood, Arkansas, United States
Ironwood Investigational Site
Anaheim, California, United States
Ironwood Investigational Site
Chula Vista, California, United States
Ironwood Investigational Site
Encinitas, California, United States
Ironwood Investigational Site
Garden Grove, California, United States
Ironwood Investigational Site
Laguna Hills, California, United States
Ironwood Investigational Site
Los Angeles, California, United States
Ironwood Investigational Site
Orange, California, United States
Ironwood Investigational Site
Sacramento, California, United States
Ironwood Investigational Site
San Carlos, California, United States
Ironwood Investigational Site
San Diego, California, United States
Ironwood Investigational Site
San Diego, California, United States
Ironwood Investigational Site
San Diego, California, United States
Ironwood Investigational Site
Colorado Springs, Colorado, United States
Ironwood Investigational Site
Bristol, Connecticut, United States
Ironwood Investigational Site
Boynton Beach, Florida, United States
Ironwood Investigational Site
Hollywood, Florida, United States
Ironwood Investigational Site
Inverness, Florida, United States
Publications
Results and literature.
PMID 25312449 ↗Chang L, Lembo AJ, Lavins BJ, Shiff SJ, Hao X, Chickering JG, Jia XD, Currie MG, Kurtz CB, Johnston JM. The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials. Aliment Pharmacol Ther. 2014 Dec;40(11-12):1302-12. doi: 10.1111/apt.12985. Epub 2014 Oct 13.PMID 21830967 ↗Lembo AJ, Schneier HA, Shiff SJ, Kurtz CB, MacDougall JE, Jia XD, Shao JZ, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Eng P, Fox SM, Johnston JM. Two randomized trials of linaclotide for chronic constipation. N Engl J Med. 2011 Aug 11;365(6):527-36. doi: 10.1056/NEJMoa1010863.
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