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Phase 3 Study of ASP0456 (Linaclotide) in IBS-C
NCT02316899Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2014
- Primary completion
- Sep 2015
- Countries
- 1
- Sponsor
- Astellas Pharma
- Modality
- Peptides
- Drugs
- linaclotide
- Conditions
- irritable bowel syndrome (IBS)
01
Overview
Phase 3, randomised, double-blind trial of linaclotide in irritable bowel syndrome (IBS) (3 arms), sponsored by Astellas Pharma. Primary endpoints: Responder rate of Global assessment of relief of IBS symptoms at 12 weeks and Responder rate of Complete Spontaneous Bowel Movement (CSBM) at 12 weeks. Started Oct 2014; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
ASP0456 (Period I)
Linaclotide administered orally once daily for 12 weeks.
Placebo (Period I)
Placebo administered orally once daily for 12 weeks.
ASP0456 (Period II)
Linaclotide administered orally once daily for 40 weeks (extension).
03
Who it enrols
Patients with constipation predominant IBS (IBS-C) with recurrent abdominal pain/discomfort and specific stool consistency criteria. Excludes patients with history of GI surgery, IBD, ischemic colitis, infectious enteritis, active peptic ulcer, or significant psychiatric/systemic disease.
04
Endpoints
Primary
Responder rate of Global assessment of relief of IBS symptoms
Responder rate of Complete Spontaneous Bowel Movement (CSBM)
Secondary
Responder rate of Spontaneous Bowel Movement (SBM)
Responder rate of Abdominal pain/discomfort relief
Changes in IBS-QOL-J scores
Incidence of adverse events
05
Results
Primary endpoints met
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