Phase 3
N=803
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
Irritable Bowel Syndrome Characterized by Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00948818 ↗Enrolled (actual)
803
Serious AEs
0.3%
Results posted
Jan 2013
Primary outcome: Primary: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks — 20; 49; 375; 356 Participants — p=0.0004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Linaclotide 290 micrograms (Drug); Matching placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Jul 2010
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 | — |
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.
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.