Phase 3
Completed N=487
Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
Source: ClinicalTrials.gov NCT01642914 ↗Enrolled (actual)
487
Serious AEs
1.7%
Results posted
Apr 2016
Primary outcomePrimary: 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder — 13; 24; 158; 129 participants — p=0.0264
◆ Published Evidence
Established
82citations · ~7 / year
Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial.
Summary
The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.
Linked Publications (2)
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Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial.
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Lessons learned: Chronic idiopathic constipation patient experiences with over-the-counter medications.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder |
13; 24; 158; 129 | 0.0264 sig |
| SECONDARY 9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder |
13; 24; 158; 129 | 0.0264 sig |
| SECONDARY Change From Baseline in 12-Week Abdominal Bloating |
-1.583; -2.476; -2.456 | — |
| SECONDARY Percent Change From Baseline in 12-week Abdominal Bloating |
-22.65; -34.52; -34.22 | — |
| SECONDARY Percent Change From Baseline in Abdominal Bloating at Week 12 |
-31.41; -45.43; -47.12 | 0.0054 sig |
| SECONDARY 6/12 Week Abdominal Bloating 30% Responder |
50; 62; 69; 121; 91; 90 | — |
| SECONDARY Change From Baseline in 12-week CSBM Frequency Rate |
1.020; 2.309; 2.292 | — |
| SECONDARY Change From Baseline in CSBM Frequency Rate at Week 1. |
0.641; 1.984; 1.746 | — |
| SECONDARY Change From Baseline in CSBM Frequency Rate at Week 4. |
1.063; 2.756; 2.678 | — |
| SECONDARY Change From Baseline in CSBM Frequency Rate at Week 8 |
1.347; 2.803; 2.319 | — |
| SECONDARY Change From Baseline in CSBM Frequency Rate at Week 12 |
1.074; 2.272; 2.488 | — |
| SECONDARY Change From Baseline in 12-Week SBM Frequency Rate |
1.480; 3.481; 3.550 | — |
| SECONDARY Change From Baseline in SBM Frequency Rate at Week 1 |
1.840; 4.168; 4.125 | — |
| SECONDARY Change From Baseline in SBM Frequency Rate at Week 4 |
1.420; 4.045; 3.872 | — |
| SECONDARY Change From Baseline in SBM Frequency Rate at Week 8 |
1.638; 3.674; 3.785 | — |
| SECONDARY Change From Baseline in SBM Frequency Rate at Week 12 |
1.288; 3.085; 2.983 | — |
| SECONDARY Change From Baseline in the Number of Days With a Spontaneous Bowel Movement (SBM) |
1.086; 2.279; 2.143 | — |
| SECONDARY SBM Within 24 Hours After the First Dose of Investigational Product |
72; 94; 94; 99; 59; 65 | 0.0006 sig |
| SECONDARY Time to Spontaneous Bowel Movement (SBM) After the First Dose of Investigational Product |
28.07; 12.53; 19.35 | .0054 sig |
| SECONDARY Change From Baseline in 12-week Stool Consistency |
0.797; 1.925; 2.304 | — |
| SECONDARY Change From Baseline in Stool Consistency at Week 12 |
0.845; 2.061; 2.358 | — |
| SECONDARY Change From Baseline in 12-week Severity of Straining |
-0.812; -1.495; -1.512 | — |
| SECONDARY Change From Baseline in Severity of Straining at Week 12 |
-1.021; -1.654; -1.686 | — |
| SECONDARY 9/12 Week Mild Straining and Diarrhea-free Responder |
15; 38; 27; 156; 115; 132 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has completed a colonoscopy according to the American Gastroenterological Association criteria with no clinically significant findings
- Patient has successfully completed protocol procedures (with no clinically significant findings)
- Patient meets protocol criteria for Chronic Constipation(CC): < 3 bowel movements per week and reports one or more of the following symptoms for at least 12 weeks:
- Straining during more than 25% of BMs
- Lumpy or hard stools during more than 25% of BMs
- Sensation of incomplete evacuation during more than 25% of BMs
- Patient demonstrates continued chronic constipation and bloating through Pretreatment Period
- Patient is compliant with Interactive voice response System (IVRS)
Exclusion Criteria
- Patient has a 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 would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments
Data sourced from ClinicalTrials.gov (NCT01642914) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.