Phase 3
Completed N=803
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
Irritable Bowel Syndrome Characterized by Constipation
Source: ClinicalTrials.gov NCT00948818 ↗
Enrolled (actual)
803
Serious AEs
0.3%
Results posted
Jan 2013
Primary outcomePrimary: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks — 20; 49; 375; 356 Participants — p=0.0004
Summary
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).
The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks |
20; 49; 375; 356 | 0.0004 sig |
| PRIMARY Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks |
25; 79; 370; 326 | <0.0001 sig |
| PRIMARY Abdominal Pain Responder, 9 Out of 12 Weeks |
107; 139; 288; 266 | 0.0262 sig |
| PRIMARY Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks. |
83; 136; 312; 269 | <0.0001 sig |
| SECONDARY 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate |
0.705; 2.272 | — |
| SECONDARY 12-Week Spontaneous Bowl Movement (SBM) Frequency Rate |
1.130; 3.898 | — |
| SECONDARY 12-Week Stool Consistency |
0.662; 2.071 | — |
| SECONDARY 12-Week Severity of Straining |
-0.651; -1.306 | — |
| SECONDARY 12-Week Change in Abdominal Pain Score |
-1.129; -1.869 | — |
| SECONDARY 12-Week Change in Abdominal Discomfort |
-1.211; -1.953 | — |
| SECONDARY 12-Week Change in Bloating |
-1.100; -1.944 | — |
| SECONDARY Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment |
117; 197; 278; 208 | — |
| SECONDARY Abdominal Pain Responder for 6 Out of 12 Weeks |
148; 203; 247; 202 | — |
| SECONDARY 12-Week Percent of Abdominal Pain-free (APF) Days |
5.31; 9.81 | — |
Eligibility Criteria
Inclusion Criteria
- Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:
- Relieved with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
- Patient reports 25% of BMs
- Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)
- Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms
Exclusion Criteria
- Patient has history of loose or watery stools for >25% of BMs
- Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility
- Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments
Data sourced from ClinicalTrials.gov (NCT00948818). 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.